Straumann USA
Medical device manufacturer in Andover, MA.
66510(k) clearances
0PMA approvals
26recalls
Device types
- NHA Abutment, Implant, Dental, Endosseous 31
- DZE Implant, Endosseous, Root-Form 27
- OAT Implant, Endosseous, Orthodontic 1
- KCZ Prosthesis, Breast, External, Used With… 1
- DZL Screw, Fixation, Intraosseous 1
- KJJ Cleanser, Root Canal 1
- DZI Drill, Bone, Powered 1
- ELB Scaler, Rotary 1
- LLZ System, Image Processing, Radiological 1
- KCT Sterilization Wrap Containers, Trays… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA)NHA · Traditional | 11/11/2024SE |
| K203753 | Straumann Surgical CassettesKCT · Traditional | 07/29/2021SE |
| K202942 | Straumann 4 mm Short ImplantsDZE · Traditional | 02/08/2021SE |
| K192401 | Straumann Screw-Retained AbutmentsNHA · Traditional | 04/06/2020SE |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant SystemsDZE · Traditional | 06/17/2019SE |
| K171784 | Straumann Dental Implant SystemDZE · Traditional | 01/19/2018SE |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…DZE · Traditional | 03/08/2017SE |
| K151590 | Straumann RN Gold Abutment for BridgeNHA · Traditional | 03/04/2016SE |
| K151328 | PURE Ceramic ImplantsDZE · Traditional | 01/11/2016SE |
| K150899 | Straumann CARES Titanium Alloy (TAN) AbutmentNHA · Traditional | 09/16/2015SE |
| K151324 | Straumann Variobase for CERECNHA · Traditional | 09/11/2015SE |
| K151247 | NC Straumann Screw Retained AbutmentsNHA · Traditional | 08/10/2015SE |
| K150814 | Straumann Screw-Retained AbutmentNHA · Traditional | 08/10/2015SE |
| K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…NHA · Traditional | 08/05/2015SE |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsDZE · Traditional | 07/24/2015SE |
| K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…NHA · Traditional | 01/09/2015SE |
| K140878 | Straumann Bone Level Tapered ImplantDZE · Traditional | 08/20/2014SE |
| K140737 | Straumann Cares Screw Retained Bars/BridgeNHA · Traditional | 08/14/2014SE |
| K141871 | Straumann Bone Level NC Angled Screw Retained AbutmentsNHA · Special | 08/07/2014SE |
| K133421 | Straumann Magellan(Tm) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewNHA · Traditional | 04/17/2014SE |
| K132219 | Straumann(R) Variobase(Tm) Abutment NNC, Straumann(R) Variobase(Tm) Abutment RN…NHA · Traditional | 02/21/2014SE |
| K132844 | Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw…NHA · Traditional | 01/15/2014SE |
| K130808 | Straumann Healing Abutments, Healing Caps, Closure ScrewsNHA · Special | 06/28/2013SE |
| K130724 | Codiagnostix Implant Planning SoftwareLLZ · Traditional | 06/28/2013SE |
| K130222 | Straumann Dental Implant SystemDZE · Traditional | 04/29/2013SE |
| K123784 | Straumann Dental Implant SystemDZE · Traditional | 04/10/2013SE |
| K122855 | TL 04.1MM Rn,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsDZE · Traditional | 12/12/2012SE |
| K122192 | NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…NHA · Traditional | 11/02/2012SE |
| K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMDZE · Traditional | 06/06/2012SE |
| K113606 | NNC Gold Abutment for BridgesNHA · Special | 01/27/2012SE |
| K113410 | NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…NHA · Special | 01/13/2012SE |
| K113283 | NNC Cementable Abutment STRAIGHT,15 Degree Angle, Type a ,15 Degree Angle, Type B,Nnc…NHA · Special | 12/28/2011SE |
| K112280 | Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumNHA · Special | 11/16/2011SE |
| K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemDZE · Traditional | 10/03/2011SE |
| K111724 | Straumann TibrushELB · Traditional | 09/12/2011SE |
| K110580 | Narrow Connection Straumann Anatomic Ips E.Max AbutmentsNHA · Traditional | 08/12/2011SE |
| K093027 | Straumann RC Temporary AbutmentsDZE · Special | 02/12/2010SE |
| K083550 | Straumann Dental Implant SystemDZE · Traditional | 02/26/2009SE |
| K082532 | Straumann Guided InstrumentsDZI · Traditional | 10/21/2008SE |
| K080286 | Cementable Abuntments; Temporary Copings; Protective CapsNHA · Special | 03/07/2008SE |
| K073628 | Synocta AbutmentsNHA · Special | 01/22/2008SE |
| K071888 | Straumann P.004 RC Gold Abutment for BridgesNHA · Traditional | 10/15/2007SE |
| K072151 | P.004 RC Cares Titanium and Ceramic AbutmentsNHA · Traditional | 09/11/2007SE |
| K071585 | P.004 Healing Abutments and Closure ScrewsNHA · Special | 07/11/2007SE |
| K063789 | WN Synocta Gold AbutmentNHA · Special | 05/10/2007SE |
| K061277 | Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic CopingNHA · Traditional | 04/12/2007SE |
| K063812 | Straumann PrefgelKJJ · Special | 01/12/2007SE |
| K060958 | Straumann Narrow Neck ImplantsDZE · Traditional | 08/24/2006SE |
| K052272 | Straumann Computer Aided Restoration ServiceNHA · Special | 01/03/2006SE |
| K050515 | Bone Block Fixation SetDZL · Special | 04/05/2005SE |
| K033243 | Iti Synocta Meso AbutmentsNHA · Special | 10/20/2003SE |
| K032498 | Dental Implant Coping (Prosthetic Accessories to the Iti Dental Implant System)NHA · Special | 08/27/2003SE |
| K031055 | Iti Dental Implant SystemDZE · Traditional | 07/07/2003SE |
| K030007 | Iti Dental Implant SystemDZE · Traditional | 03/31/2003SE |
| K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant SystemDZE · Special | 09/19/2002SE |
| K012757 | Iti Dental Implant SystemDZE · Special | 08/22/2001SE |
| K010291 | Iti Dental Implant SystemDZE · Traditional | 05/10/2001SE |
| K002374 | Iti Dental Implant System Monotype ImplantDZE · Traditional | 11/01/2000SE |
| K994119 | Synocta Angled AbutmentsDZE · Traditional | 03/17/2000SE |
| K990342 | Synocta ProstheticsDZE · Traditional | 07/20/1999SE |
| K984104 | Iti Dental Implant SystemDZE · Traditional | 05/13/1999SE |
| K990458 | Straumann Extraoral Implant SystemKCZ · Traditional | 04/16/1999SE |
| K982509 | Ortho Implant and AccessoriesOAT · Traditional | 09/30/1998SE |
| K973353 | Bonding BaseDZE · Traditional | 12/02/1997SE |
| K971578 | Endosseous Dental ImplantDZE · Traditional | 06/30/1997SE |
| K962647 | Angled AbutmentDZE · Traditional | 10/07/1996SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3173-2026 | GM Helix Implant, REF: 109.984;There is a discrepancy between the product identification on the packaging and the dimensions of the implant… | 08/12/2026Open, Classified |
| Z-2935-2026 Class II | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim…Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain… | 07/16/2026Open, Classified |
| Z-2929-2026 Class II | GM Helix Implant, Endosseous Dental Implant Article No. 109.984There may be a mismatch between the implant contained inside the packaging and the information described on… | 07/13/2026Open, Classified |
| Z-1995-2026 Class II | Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental…Includes an incorrect screw seat interface. | 03/27/2026Open, Classified |
| Z-1994-2026 Class II | Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304.…Includes an incorrect screw seat interface. | 03/27/2026Open, Classified |
| Z-1633-2026 Class II | Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a… | 03/17/2026Open, Classified |
| Z-1632-2026 Class II | Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a… | 03/17/2026Open, Classified |
| Z-1337-2026 Class III | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POMThe mix up of the impression caps provided in the package. The provided impression caps are magenta instead… | 01/06/2026Open, Classified |
| Z-0582-2026 Class II | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;The possibility for this product that is intended for demonstration purposes only to be placed in patients. | 10/17/2025Open, Classified |
| Z-1863-2025 Class II | GM Helix Acqua Implant, Article Number: 140.985It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | 05/01/2025Open, Classified |
| Z-1862-2025 Class II | GM Helix Acqua Implant, Article Number: 140.984It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | 05/01/2025Open, Classified |
| Z-1671-2025 Class II | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.Incorrect blister labelling. | 04/17/2025Open, Classified |
| Z-1861-2025 Class II | Plus Initial Drill, Article Number: 103.170;The referred batch was produced without the laser engraving of 7 mm. | 04/14/2025Open, Classified |
| Z-1561-2025 Class II | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;The devices are missing the laser marked depth markings. | 03/08/2025Open, Classified |
| Z-0513-2022 Class II | Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure… | 11/30/2021Terminated |
| Z-0512-2022 Class II | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item…Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure… | 11/30/2021Terminated |
| Z-2336-2021 Class II | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and…Product label intended for the European community was distributed to the USA market via their US… | 06/25/2021Open, Classified |
| Z-2198-2021 Class II | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article…Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not… | 05/27/2021Terminated |
| Z-0981-2015 Class II | Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number…Drill set may contain incorrect drill. | 10/27/2014Terminated |
| Z-0174-2015 Class II | Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number:…Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) | 09/24/2014Terminated |
| Z-0117-2015 Class II | Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article…Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) | 09/19/2014Terminated |
| Z-2161-2012 Class II | Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant…Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC… | 07/11/2012Terminated |
| Z-1351-2012 | Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S.…Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN… | 03/12/2012Terminated |
| Z-1037-2008 | Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04…Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection… | 01/10/2008Terminated |
| Z-0278-2008 | Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC…Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during… | 09/28/2007Terminated |
| Z-0277-2008 | Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA.…Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during… | 09/28/2007Terminated |