Bone Grafting Material, Synthetic
FDA product code LYC · Class II (moderate risk) · 21 CFR 872.3930 · Dental
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
231510(k) clearances
0PMA approvals
12recalls
Implantimplanted device
Manufacturers
- Bio-Interfaces, Inc. 15
- Ceramed Corp. 13
- Geistlich Pharma AG 11
- Novabone Products, LLC 9
- Unicare Biomedical, Inc. 7
- Interpore Intl. 6
- Coors Biomedical Co. 6
- W. L. Gore & Associates, Inc. 5
- Lifecore Biomedical, Inc. 4
- Usbiomaterials Corp. 4
- Etex Corp. 4
- Genoss Co., Ltd. 4
- Biomet, Inc. 3
- Impladent , Ltd. 3
- Orthovita, Inc. 3
- Orthomatrix, Inc. 3
- Biocomposites, Ltd. 3
- Imtec Corp. 3
- Sterling Drug, Inc. 3
- Carbomedics, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253317 | Cytrans ElashieldLYC · Traditional | GC America, Inc. | 07/06/2026SE |
| K253883 | Bonalive MaxillofacialLYC · Special | Bonalive , Ltd. | 05/14/2026SE |
| K251818 | Bontree PlusLYC · Traditional | Hudens Bio Co., Ltd. | 03/06/2026SE |
| K244006 | FG Bone Graft MLYC · Traditional | Full Golden Biotech Co., Ltd. | 09/17/2025SE |
| K243745 | FG Bone Graft BLYC · Traditional | Full Golden Biotech Corporation | 08/29/2025SE |
| K241186 | Synthetic Bone Graft ParticulateLYC · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 02/21/2025SE |
| K213260 | CMFlexTMLYC · Traditional | Dimension Inx Corp. | 12/30/2022SE |
| K202675 | InRoad® Dental Synthetic Bone GraftLYC · Traditional | Osteogene Tech Corp | 03/04/2022SE |
| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
| K201051 | Straumann BoneCeramicLYC · Traditional | Institut Straumann AG | 09/24/2020SE |
| K192597 | Cytrans GranulesLYC · Abbreviated | GC America, Inc. | 08/17/2020SE |
| K153676 | Osteon IIILYC · Traditional | Genoss Co., Ltd. | 09/14/2016SE |
| K153230 | ShefaBone SCPC Resorbable Bone GraftLYC · Traditional | The Implantech Inc./Shefabone | 07/14/2016SE |
| K140374 | Mastergraft PuttyLYC · Traditional | Medtronic Sofamor Danek USA, Inc. | 06/10/2014SE |
| K121177 | Bond ApatiteLYC · Traditional | Augma Biomaterials, Ltd. | 12/05/2013SE |
| K131385 | Easy-GraftLYC · Traditional | Degradable Solutions AG | 09/27/2013SE |
| K111105 | Curasan Osseolive DentalLYC · Abbreviated | Curasan AG | 12/20/2012SE |
| K113282 | Cerasorb Dental,Ceradorb M Dental, Cerasorb PerioLYC · Special | Riemser Arzeimittel AG | 09/20/2012SE |
| K122240 | Bone Plus BCP Eagle EyeLYC · Special | Megagen Implant Co., Ltd. | 08/21/2012SE |
| K113049 | Socket GraftLYC · Traditional | Steiner Laboratories | 01/27/2012SE |
| K112716 | Osteon IILYC · Traditional | Genoss Co., Ltd. | 01/17/2012SE |
| K110198 | Blue Sky Bio TCPLYC · Traditional | Blue Sky Bio, LLC | 12/22/2011SE |
| K112428 | Novabone Dental Morsels - Bioactive Synthetic Bone GraftLYC · Traditional | Novabone Products, LLC | 12/16/2011SE |
| K111087 | FoundationLYC · Traditional | Olympus Terumo Biomaterials Corporation | 11/29/2011SE |
| K103820 | Reprobone Dental Grafting MaterialLYC · Traditional | Ceramisys, Ltd. | 11/03/2011SE |
| K110449 | Endobon Xenograft GranulesLYC · Traditional | Biomet 3i | 05/13/2011SE |
| K102208 | NanogenLYC · Traditional | Orthogen, LLC | 05/06/2011SE |
| K101827 | OsteoscafLYC · Traditional | Texas Innovative Medical Devices (Dba) Skeletal | 04/20/2011SE |
| K103709 | Ceracell DentalLYC · Abbreviated | Curasan AG | 03/10/2011SE |
| K102872 | Osbone DentalLYC · Traditional | Curasan AG | 01/12/2011SE |
| K100883 | CarrigenLYC · Traditional | Etex Corp. | 12/21/2010SE |
| K102812 | Gamma-Bsm; Beta-Bsm; EquivaboneLYC · Special | Etex Corporation | 12/03/2010SE |
| K102015 | Osteon, Osteon Sinus, Osteon LiftingLYC · Special | Genoss Co., Ltd. | 11/19/2010SE |
| K101718 | OsseoconductLYC · Traditional | Steiner Laboratories Div of Steiner Healthcare… | 10/26/2010SE |
| K101014 | Bond BoneLYC · Traditional | Mis Implants Technologies , Ltd. | 10/21/2010SE |
| K091618 | VitomatrixLYC · Traditional | Orthovita, Inc. | 09/27/2010SE |
| K101426 | Ceros TCP GranulesLYC · Traditional | Mathys, Ltd. | 09/15/2010SE |
| K090950 | Bone Plus BCPLYC · Traditional | Megagen Implant Co., Ltd. | 07/02/2010SE |
| K092194 | Polybone DentalLYC · Traditional | Kyung Won Medical Co., Ltd. | 06/16/2010SE |
| K093390 | Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025LYC · Special | Depuy Spine, Inc. | 05/25/2010SE |
| K093871 | Periophil B-TcpLYC · Traditional | Cytophil, Inc. | 04/22/2010SE |
| K100671 | Novabone Dental Putty-Bioactive Synthetic Bone GraftLYC · Special | Novabone Products, LLC | 03/30/2010SE |
| K093122 | Mbcp+LYC · Traditional | Biomatlante | 03/15/2010SE |
| K092087 | Medtronic Dental TCPLYC · Traditional | Medtronic Sofamor Danek USA, Inc. | 12/30/2009SE |
| K091729 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneLYC · Traditional | Etex Corp. | 12/23/2009SE |
| K092788 | Periophil BiphasicLYC · Traditional | Cytophil, Inc. | 12/18/2009SE |
| K083372 | Arrowbone-A, Arrowbone-BLYC · Traditional | Brainbase Corporation | 12/08/2009SE |
| K092567 | Modification to UnigraftLYC · Traditional | Unicare Biomedical, Inc. | 11/25/2009SE |
| K090850 | Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteLYC · Traditional | Apatech , Ltd. | 07/30/2009SE |
| K091484 | Novabone Dental Putty - Bioactive Synthetic Bone GraftLYC · Special | Novabone Products, LLC | 06/15/2009SE |
| K090793 | Bongros HaLYC · Traditional | Bioalpha, Inc. | 05/19/2009SE |
| K090083 | Cytoflex Resorb, Model C03-0010 Through C03-090LYC · Traditional | Unicare Biomedical, Inc. | 03/23/2009SE |
| K083858 | Bond BoneLYC · Traditional | Augma Biomaterials, Ltd. | 03/17/2009SE |
| K083005 | NangelLYC · Traditional | Teknimed, S.A. | 03/04/2009SE |
| K082286 | BioactysLYC · Abbreviated | Graftys | 02/24/2009SE |
| K083742 | Synoss Collagen Synthetic Mineral-Collagen Bone Graft MatrixLYC · Traditional | Collagen Matrix, Inc. | 02/12/2009SE |
| K082917 | Mastergraft Resorbable Ceramic GranulesLYC · Traditional | Medtronic Sofamor Danek | 01/09/2009SE |
| K081784 | Mastergraft PuttyLYC · Traditional | Medtronic Sofamor Danek | 09/17/2008SE |
| K082383 | Fortoss VitalLYC · Special | Biocomposites, Ltd. | 09/05/2008SE |
| K081432 | Healos II Bone Graft SubstituteLYC · Traditional | Depuy Spine, Inc. | 08/29/2008SE |
| K081721 | Tricos a Resorbable SubstituteLYC · Traditional | Baxter Healthcare Corp | 08/06/2008SE |
| K081561 | Osferion DLYC · Traditional | Olympus Terumo Biomaterials Corporation | 07/28/2008SE |
| K080772 | Bonemedik-DmLYC · Traditional | Meta Biomed Co., Ltd. | 06/03/2008SE |
| K080308 | Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldLYC · Abbreviated | Bioscaffold International Pte, Ltd. | 04/14/2008SE |
| K073571 | Tricos T Resorbable Bone SubstituteLYC · Abbreviated | Baxter Healthcare Corporation | 04/08/2008SE |
| K072397 | Synoss Synthetic Bone Graft MaterialLYC · Traditional | Collagen Matrix, Inc. | 10/18/2007SE |
| K071817 | OSTEOGRAF/N-300LYC · Special | Dentsply Interntional | 09/04/2007SE |
| K072052 | OSTEOGRAF/D-300LYC · Special | Dentsply International, Inc. | 08/08/2007SE |
| K072057 | OSTEOGRAF/LD-300LYC · Special | Dentsply International, Inc. | 08/06/2007SE |
| K072056 | OSTEOGRAF/D-700LYC · Special | Dentsply International, Inc. | 08/06/2007SE |
| K072058 | Modification to: OSTEOGRAF/N-700LYC · Special | Dentsply Interntional | 08/03/2007SE |
| K070784 | Inion BiorestoreLYC · Traditional | Inion OY | 07/24/2007SE |
| K070055 | Bonalive Granules and Bonalive PlatesLYC · Traditional | Vivoxid , Ltd. | 06/25/2007SE |
| K063634 | RTR SyringeLYC · Abbreviated | Septodont | 05/11/2007SE |
| K062834 | Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050LYC · Abbreviated | Genoss Co., Ltd. | 04/24/2007SE |
| K062102 | OdoncerLYC · Traditional | Teknimed, S.A. | 04/16/2007SE |
| K063596 | Perioglas Putty-Bioactive Bone Graft GelLYC · Traditional | Novabone Products, LLC | 02/22/2007SE |
| K063549 | Novabone Dental Putty-Bioactive Synthetic Bone GraftLYC · Traditional | Novabone Products, LLC | 02/12/2007SE |
| K063010 | Regen BiocementLYC · Traditional | Steiner Laboratories | 11/28/2006SE |
| K052493 | Socket GraftLYC · Traditional | Steiner Laboratories | 06/09/2006SE |
| K060732 | MBCP GelLYC · Traditional | Biomatlante | 06/02/2006SE |
| K060285 | Bonegen - TRLYC · Traditional | Bio-Lok Intl., Inc. | 03/16/2006SE |
| K053374 | Ossaplast Dental (Particle Size of 500 to 1000 Um to 2000 Um)LYC · Abbreviated | Ossacur AG | 02/21/2006SE |
| K053387 | Perioglas Bone Graft ParticulateLYC · Traditional | Novabone Products, LLC | 02/14/2006SE |
| K053022 | Synthes (USA) Chronos-Beta-TcpLYC · Traditional | Synthes (Usa) | 01/23/2006SE |
| K051885 | MBCPLYC · Traditional | Biomatlante | 09/16/2005SE |
| K051091 | SynthograftLYC · Traditional | Bicon, Inc. | 09/01/2005SE |
| K050170 | Fortoss Vital Bone Graft SubstituteLYC · Traditional | Biocomposites, Ltd. | 08/26/2005SE |
| K050984 | BioplantLYC · Traditional | Kerr Dental Materials Center | 08/11/2005SE |
| K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioLYC · Abbreviated | Curasan Ag, Frankfurt Facility | 07/22/2005SE |
| K042583 | Calc-I-OssLYC · Traditional | Ultradent Products, Inc. | 07/19/2005SE |
| K051381 | Ace Surgicalplaster Calcium Sulface HemihydrateLYC · Traditional | Ace Surgical Supply Co., Inc. | 07/15/2005SE |
| K050260 | Bioresorb Macro PoreLYC · Traditional | Oraltronics Dental Implant Technology GmbH | 07/15/2005SE |
| K042730 | Calforma Calcium Sulfate Bone Graft Barrier, Model 0.5G/1.0GLYC · Traditional | Lifecorebiomedical | 02/14/2005SE |
| K030052 | OstimLYC · Traditional | Heraeus Kulzer, Inc. | 12/06/2004SE |
| K042706 | Ossatura DentalLYC · Traditional | Isotis Orthobiologics, Inc. | 10/20/2004SE |
| K040783 | FoundationLYC · Traditional | Terumo Corp. | 10/13/2004SE |
| K031813 | Ossatura DentalLYC · Traditional | Isotis NV | 08/20/2004SE |
| K041324 | Calmatrix Calcium Sulfate Bone Graft BinderLYC · Traditional | Lifecore Biomedical, Inc. | 07/19/2004SE |
| K030195 | BBP Bone SubstitutesLYC · Traditional | Oct, USA, Inc. | 06/17/2004SE |
| K040646 | Straumann GranulesLYC · Traditional | The Straumann Co. | 05/03/2004SE |
| K033098 | Osteogen SBRGLYC · Traditional | Impladent , Ltd. | 04/27/2004SE |
| K033994 | Novabone-Bbg-Resorbable Bone Graft SubstituteLYC · Traditional | Novabone Products, LLC | 03/25/2004SE |
| K033729 | Collagen Dental Wound DressingsLYC · Traditional | Collagen Matrix, Inc. | 03/17/2004SE |
| K040278 | Perioglas-Bioglass Bone Graft SubstituteLYC · Special | Novabone Products, LLC | 03/01/2004SE |
| K033110 | C-GraftLYC · Traditional | The Clinician'S Preference, LLC | 12/10/2003SE |
| K031073 | Perioglas Plus - Settable Bone Graft SubstituteLYC · Traditional | Novabone Products, LLC | 11/05/2003SE |
| K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3LYC · Traditional | Bioform, Inc. | 06/27/2003SE |
| K023998 | Theriridge Block, Bone Graft SubstituteLYC · Traditional | Therics, Inc. | 03/26/2003SE |
| K023799 | Frios AlgiporeLYC · Traditional | Friadent GmbH | 02/05/2003SE |
| K020720 | OssiformLYC · Traditional | Unicare Biomedical, Inc. | 05/07/2002SE |
| K020396 | Biocellect -PerioLYC · Traditional | Imtec Corp. | 04/10/2002SE |
| K014289 | Orthoss Resorbable Bone Void FillerLYC · Traditional | Geistlich-Pharma | 03/28/2002SE |
| K013346 | Gore Drapeable St/Lt Regenerative MembraneLYC · Traditional | W. L. Gore & Associates, Inc. | 12/19/2001SE |
| K012144 | CytoflexLYC · Traditional | Unicare Biomedical, Inc. | 10/01/2001SE |
| K012047 | 3I Calcium Sulfate Bone CementLYC · Traditional | Implant Innovations, Inc. | 09/19/2001SE |
| K011403 | Surgiplaster Calcium Sulfate HemihydrateLYC · Traditional | Orthogen Corp. | 09/11/2001SE |
| K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model Sk/S, Smartjet Bone Graft…LYC · Traditional | Harvest Technologies, Corp. | 07/03/2001SE |
| K010775 | BiocellectLYC · Traditional | Imtec Corp. | 06/12/2001SE |
| K010701 | Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void FillerLYC · Traditional | Medtronic Sofamor Danek USA, Inc. | 06/05/2001SE |
| K003494 | Mimix Bone Replacement SystemLYC · Traditional | Biomet, Inc. | 04/09/2001SE |
| K010320 | Modification to Symphony Graft Delivery SystemLYC · Special | Depuyacromed | 03/01/2001SE |
| K003493 | 3I Calcium Sodium Phosphate Bone CementLYC · Traditional | Biomet, Inc. | 02/09/2001SE |
| K003286 | Symphony Graft Delivery SystemLYC · Traditional | Depuyacromed | 01/18/2001SE |
| K003457 | UnigraftLYC · Traditional | Unicare Biomedical | 01/09/2001SE |
| K994137 | Atrisorb-D Freeflow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4%…LYC · Traditional | Atrix Laboratories, Inc. | 09/13/2000SE |
| K001598 | Biobar, Implantable Biodegradable Collagen Membrane for Guided Bone RegenerationLYC · Traditional | Col-Bar , Ltd. | 08/22/2000SE |
| K970569 | Bio-BlocksLYC · Traditional | Geistlich-Pharma | 08/14/2000SE |
| K000633 | Synthetic Glass Bone Graft MaterialLYC · Traditional | Blue Sky Bio | 05/25/2000SE |
| K993610 | Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250LYC · Traditional | Osteogenics Biomedical, Inc. | 03/02/2000SE |
| K000149 | Novabone-Bioglass Bone Graft ParticulateLYC · Special | Usbiomaterials Corp. | 02/07/2000SE |
| K993784 | UnigraftLYC · Traditional | Unicare Biomedical | 01/27/2000SE |
| K993238 | Fortoss-CemaLYC · Traditional | Biocomposites, Ltd. | 01/14/2000SE |
| K990537 | Osteo-Pin Membrane Fixation PinLYC · Traditional | Luitpold Pharmaceuticals, Inc. | 11/19/1999SE |
| K992416 | Perioglas- Bioglass Bone Graft ParticulateLYC · Traditional | Usbiomaterials Corp. | 10/15/1999SE |
| K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen MenbraneLYC · Special | Integra Lifesciences Corp. | 07/26/1999SE |
| K983104 | Norian Periodontal/Dental Cement (PDC)LYC · Traditional | Norian Corp. | 02/12/1999SE |
| K982699 | UnigrafeLYC · Traditional | Unicare Biomedical | 10/20/1998SE |
| K974399 | Bio-Oss CollagenLYC · Traditional | Geistlich-Pharma | 09/16/1998SE |
| K970321 | Bio-Oss Anorganic Bovine BoneLYC · Traditional | Geistlich-Pharma | 09/15/1998SE |
| K972817 | Resor-Pin Resorbable Membrane PinLYC · Traditional | Geistlich-Pharma | 07/24/1998SE |
| K981182 | OSTEOGRAF/N-300LYC · Traditional | Ceramed Dental, LLC | 07/02/1998SE |
| K981214 | OSTEOGRAF/N-700LYC · Traditional | Ceramed Dental, LLC | 06/26/1998SE |
| K980679 | EndobonLYC · Traditional | Biomet, Inc. | 04/03/1998SE |
| K973594 | Gore Resolut XT Regenerative MaterialLYC · Traditional | W. L. Gore & Associates, Inc. | 12/17/1997SE |
| K972842 | Interpore Inducer Bone Graft Delivery SyringeLYC · Traditional | Interpore Intl. | 10/30/1997SE |
| K972278 | Cytoplast Regentex Titanium 250LYC · Traditional | Osteogenics Co. | 08/06/1997SE |
| K962548 | BSM Bone Substitute Material KitLYC · Traditional | Etex Corp. | 08/05/1997SE |
| K970884 | Resolut Regenerative MaterialLYC · Traditional | W. L. Gore & Associates, Inc. | 05/08/1997SE |
| K964342 | Cytoplast GBRLYC · Traditional | Osteogenics Co. | 03/11/1997SE |
| K960267 | TBM SpongeLYC · Traditional | Biocoll Laboratories, Inc. | 11/05/1996SE |
| K940643 | Osmed Epi-GuideLYC · Traditional | Thm Biomedical, Inc. | 10/15/1996SE |
| K962624 | Resolut Regenerative MaterialLYC · Traditional | W. L. Gore & Associates, Inc. | 10/03/1996SE |
| K962494 | Perioglas - Bioglass Bone Graft ParticulateLYC · Traditional | Usbiomaterials Corp. | 09/20/1996SE |
| K962838 | Permaridge SyringeLYC · Traditional | Ceramed Corp. | 08/20/1996SE |
| K962786 | Osteograf Stainless Steel SyringLYC · Traditional | Ceramed Corp. | 08/01/1996SE |
| K960348 | OSTEOGRAF/N-300 HydroxylapatiteLYC · Traditional | Ceramed Corp. | 04/22/1996SE |
| K960368 | OSTEOGRAFT/N-700 HydroxylaptiteLYC · Traditional | Ceramed Corp. | 04/18/1996SE |
| K960353 | OSTEOGRAF/LD-300 HydroxylapatiteLYC · Traditional | Ceramed Corp. | 04/18/1996SE |
| K960361 | Permamesh-D Hydroxylapatite MatrixLYC · Traditional | Ceramed Corp. | 04/15/1996SE |
| K960164 | Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140LYC · Traditional | Bio-Interfaces, Inc. | 04/10/1996SE |
| K950306 | Imtec BiobarrierLYC · Traditional | Imtec Corp. | 02/06/1996SE |
| K955096 | Capset Calcium Sulfate Bone Graft PlasterLYC · Traditional | Lifecore Biomedical, Inc. | 01/23/1996SE |
| K954763 | Bio-Interfaces, Inc,. Bii-PlastLYC · Traditional | Bio-Interfaces, Inc. | 01/04/1996SE |
| K954631 | Osteograf/N-Blocck HydroxylapatiteLYC · Traditional | Ceramed Corp. | 01/02/1996SE |
| K952922 | Biogran Bioactive Glass Synthetic Bone Graft MaterialLYC · Traditional | Orthovita Co. | 12/19/1995SE |
| K952619 | Bio-Oss CeramicLYC · Traditional | Geistlich-Pharma | 08/28/1995SE |
| K952618 | Bio-OssLYC · Traditional | Geistlich-Pharma | 08/28/1995SE |
| K950598 | Bioresorbable Calcium Phosphate Particles - Bll-GraftLYC · Traditional | Bio-Interfaces, Inc. | 08/23/1995SE |
| K924408 | Colla-Tec Absorbable Collagen MembraneLYC · Traditional | Colla-Tec, Inc. | 08/22/1995SE |
| K952617 | Bio-OssLYC · Traditional | Geistlich-Pharma | 08/07/1995SE |
| K923310 | Osteogen (Ha Resorb)LYC · Traditional | Impladent | 05/31/1995SE |
| K950567 | Bio-Apatite 6140 Ha ParticlesLYC · Traditional | Bio-Interfaces, Inc. | 05/09/1995SE |
| K950511 | Bll-Fil 6140 ParticlesLYC · Traditional | Bio-Interfaces, Inc. | 04/27/1995SE |
| K943186 | Capset Calcium Sulfate Bone Graft PlasterLYC · Traditional | Lifecore Biomedical, Inc. | 04/10/1995SE |
| K950165 | Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000…LYC · Traditional | Interpore Intl. | 03/28/1995SE |
| K932866 | Resolut Regenerative MaterialLYC · Traditional | W. L. Gore & Associates, Inc. | 03/28/1995SE |
| K941780 | Orthovita BiogranLYC · Traditional | Orthovita Co. | 02/10/1995SE |
| K942946 | OSTEOGRAF/D-100 HydroxylapatiteLYC · Traditional | Ceramed Corp. | 10/05/1994SE |
| K942212 | OSTEOGRAF/LD-300 HydroxylapatiteLYC · Traditional | Ceramed Corp. | 08/23/1994SE |
| K934049 | Bii-Pore(Tm) Canal Wall ProsthesisLYC · Traditional | Bio-Interfaces, Inc. | 07/19/1994SE |
| K933688 | Bii-PoreLYC · Traditional | Bio-Interfaces, Inc. | 07/19/1994SE |
| K934430 | Bon Apatite Ha ParticlesLYC · Traditional | Bio-Interfaces, Inc. | 05/18/1994SE |
| K934947 | Bii-PlastLYC · Traditional | Bio-Interfaces, Inc. | 01/26/1994SE |
| K930115 | PerioglassLYC · Traditional | Usbiomaterials Corp. | 11/04/1993SE |
| K924287 | 710 Porous Ha Particles-Bii-PoreLYC · Traditional | Bio-Interfaces, Inc. | 04/30/1993SE |
| K924288 | B1018 Porous Ha Bii-PoreLYC · Traditional | Bio-Interfaces, Inc. | 04/14/1993SE |
| K924286 | 4060 Porous Ha Particules Bii PoreLYC · Traditional | Bio-Interfaces, Inc. | 04/14/1993SE |
| K922487 | Bio-Interfaces 1840 Porous Ha Particles-Bii-PoreLYC · Traditional | Bio-Interfaces, Inc. | 04/14/1993SE |
| K921776 | 1840 Ha ParticlesLYC · Traditional | Bio-Interfaces, Inc. | 12/04/1992SE |
| K920508 | Bio-Oss BlocksLYC · Traditional | Geistlich-Pharma | 11/24/1992SE |
| K921468 | Permamesh Hydroxylapatite MatrixLYC · Traditional | Ceramed Corp. | 08/21/1992SN |
| K921469 | OSTEOGRAF/N-700 Natural Hydroxylapatite 18-40 MeshLYC · Traditional | Ceramed Corp. | 06/25/1992SE |
| K910432 | Hapset Hydroxylapatite Bone Graft PlasterLYC · Traditional | Lifecore Biomedical, Inc. | 05/01/1991SE |
| K900136 | Ceros 80 (Ha)LYC · Traditional | Mathys Corp. | 01/29/1991SE |
| K902295 | Osteograf/N Natural Hydroxylapatite, 40-60 MeshLYC · Traditional | Ceramed Corp. | 12/11/1990SE |
| K891173 | Osteograf/P Periodontal Hydroxylapatite, 40-60LYC · Traditional | Ceramed Corp. | 09/01/1989SE |
| K885067 | 4060 Ha ParticlesLYC · Traditional | Bio-Interfaces, Inc. | 01/11/1989SE |
| K880371 | Bioglass Dental Endosseous Ridge MaintainerLYC · Traditional | American Biomaterials Corp. | 11/18/1988SE |
| K882098 | Dentoridge(Tm) HydroxyylapatiteLYC · Traditional | Norian Corp. | 06/13/1988SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0414-2019 Class III | BioMend Extend, REF# 0142Z, Synthetic bone grafting material.There is a possibility that the product was packaged in the wrong box. Specifically, the product may have… | Collagen Matrix, Inc. | 08/16/2018Terminated |
| Z-0113-2017 Class II | Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable…The device has the potential to be packaged in the wrong product box. | Osteogenics Biomedical, Inc. | 09/07/2016Terminated |
| Z-0788-2016 Class II | Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in…Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its… | Biomet France SARL | 01/21/2016Terminated |
| Z-1233-2014 Class III | ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute…Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have… | Biomet 3i, LLC | 10/03/2013Terminated |
| Z-1301-2013 Class II | BioMend Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane is an…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1299-2013 Class II | BioMend Extend" Absorbable Collagen Membrane BioMend Extend" Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1298-2013 Class II | OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-0401-2013 Class II | BioPlant, a dental bone grafting material. BioPlant has been assigned the product code…The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or… | Kerr Corporation | 10/25/2012Terminated |
| Z-1012-2012 | Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0…Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone… | Cytophil, Inc | 01/11/2012Terminated |
| Z-1806-2010 | Calcium Sulfate Hemihydrate 1.0 gram kits.Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate… | Ace Surgical Supply Co., Inc. | 05/14/2010Terminated |
| Z-1805-2010 | Calcium Sulfate Hemihydrate 0.5 gram kits.Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate… | Ace Surgical Supply Co., Inc. | 05/14/2010Terminated |
| Z-0974-2009 | Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting…Fragments of the glass vial may be present in some of the packages from these lots. | Zimmer Inc. | 01/22/2009Terminated |