Bisco, Inc.
Medical device manufacturer in Schaumburg, IL.
88510(k) clearances
0PMA approvals
2recalls
Device types
- EBF Material, Tooth Shade, Resin 30
- KLE Agent, Tooth Bonding, Resin 18
- EMA Cement, Dental 9
- EBD Coating, Filling Material, Resin 6
- DYH Adhesive, Bracket And Tooth Conditioner… 4
- EJK Liner, Cavity, Calcium Hydroxide 4
- EBC Sealant, Pit And Fissure, And Conditioner 3
- EBI Resin, Denture, Relining, Repairing, Rebasing 3
- EBZ Activator, Ultraviolet, For Polymerization 2
- EBG Crown And Bridge, Temporary, Resin 2
- LBH Varnish, Cavity 2
- EIH Powder, Porcelain 1
- ELR Post, Root Canal 1
- KOJ Airbrush 1
- KIF Resin, Root Canal Filling 1
- PME External Cleaning Solution 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250156 | Choice 2 DCEMA · Traditional | 07/11/2025SE |
| K242816 | QuantiumEBF · Traditional | 12/17/2024SE |
| K192007 | TheraBase, TheraBase CaEMA · Traditional | 03/17/2020SE |
| K182917 | FluoroCalLBH · Traditional | 11/18/2019SE |
| K180344 | TheraCal DCEJK · Special | 04/05/2018SE |
| K171147 | REVEAL BulkEBF · Traditional | 08/04/2017SE |
| K162598 | HAPI SealEBC · Traditional | 05/23/2017SE |
| K163171 | CeraCleanPME · Traditional | 04/14/2017SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
| K161256 | TheraCemEMA · Traditional | 07/29/2016SE |
| K143292 | TheraCal DCEJK · Traditional | 08/04/2015SE |
| K141439 | Orthodontic Acrylic (Not Finalized)EBI · Traditional | 09/12/2014SE |
| K131734 | All-Bond Universal SC (Not Finalized)KLE · Traditional | 04/11/2014SE |
| K123653 | Seal Block Pro (Not Finalized), Seal Block OTC (Not Finalized)LBH · Traditional | 06/03/2013SE |
| K113401 | ORTHO-1(NOT Finalized)DYH · Traditional | 02/07/2012SE |
| K112118 | DreambondKLE · Traditional | 11/17/2011SE |
| K103514 | Pro-V CoatEBG · Traditional | 05/25/2011SE |
| K102844 | All-Bound 3KLE · Special | 10/29/2010SE |
| K101787 | Duolink IIEMA · Traditional | 10/08/2010SE |
| K101485 | All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with…KLE · Traditional | 08/26/2010SE |
| K093470 | Core-Flo D/CEBF · Traditional | 02/17/2010SE |
| K091705 | Primer PlusKLE · Traditional | 08/28/2009SE |
| K082449 | Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012EMA · Special | 09/25/2008SE |
| K073263 | Pro-VEBG · Traditional | 02/14/2008SE |
| K063780 | Ace Bond SeKLE · Special | 01/19/2007SE |
| K063237 | Theracal LCEJK · Traditional | 12/08/2006SE |
| K060701 | Biscem Translucent, Biscem OpaqueEMA · Traditional | 05/15/2006SE |
| K052122 | Bisco LEDEBZ · Traditional | 03/29/2006SE |
| K051999 | Biscover LEDEBD · Traditional | 08/22/2005SE |
| K050647 | All-In-OneKLE · Traditional | 04/20/2005SE |
| K043168 | Biscover LVEBD · Traditional | 02/01/2005SE |
| K042804 | Tescera Opaquer Powder/Sculpting ResinEBF · Traditional | 02/01/2005SE |
| K034024 | Tescera Fiber Bundles, Fiber Mesh and Fiber CylindersEBI · Traditional | 03/19/2004SE |
| K033585 | DiapexKIF · Traditional | 01/16/2004SE |
| K033521 | BisblockEJK · Traditional | 01/16/2004SE |
| K033472 | Tescera U-Bar and BarrelsEBI · Traditional | 01/15/2004SE |
| K032597 | Biscem GiEMA · Traditional | 11/04/2003SE |
| K030951 | Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120PEBF · Traditional | 06/06/2003SE |
| K030585 | Sculpting ResinEBD · Traditional | 04/28/2003SE |
| K030354 | Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity ModifierEBD · Special | 02/19/2003SE |
| K024046 | Tescera Glazing Resin, Model T-1804, Biscover XT, Model G-93220PEBD · Traditional | 02/06/2003SE |
| K021503 | UninhibitedEBD · Traditional | 08/01/2002SE |
| K013519 | SimpleKLE · Traditional | 01/17/2002SE |
| K012032 | First SpepDYH · Traditional | 09/17/2001SE |
| K012180 | A-WearEBF · Traditional | 09/05/2001SE |
| K011159 | One-Step PlusEMA · Traditional | 06/08/2001SE |
| K010196 | Total CureEBF · Traditional | 04/05/2001SE |
| K003361 | Renew LS-2EBF · Traditional | 11/28/2000SE |
| K003317 | Renew LS-1EBF · Traditional | 11/21/2000SE |
| K000426 | Vip- Variable Intensity PolymerizerEBZ · Traditional | 04/12/2000SE |
| K993488 | Light-CoreEBF · Traditional | 11/10/1999SE |
| K993192 | IllusionEBF · Traditional | 10/27/1999SE |
| K992248 | Post Cement Hi-XEBF · Traditional | 08/25/1999SE |
| K984112 | AdventEBF · Traditional | 12/22/1998SE |
| K982729 | RenewEBF · Traditional | 09/15/1998SE |
| K982645 | PyramidEBF · Traditional | 09/02/1998SE |
| K974483 | Ntl-FlowEBF · Traditional | 02/09/1998SE |
| K970484 | Accu-PrepKOJ · Traditional | 07/01/1997SE |
| K964931 | White CoreEBF · Traditional | 02/10/1997SE |
| K964000 | Bisfil 2BKLE · Traditional | 11/05/1996SE |
| K962946 | Ortho-OneDYH · Traditional | 09/03/1996SE |
| K961822 | Wet-PrepKLE · Traditional | 06/11/1996SE |
| K955292 | AelitefloEBF · Traditional | 12/13/1995SE |
| K945370 | C-PostELR · Traditional | 03/31/1995SE |
| K945604 | EcliptomerKLE · Traditional | 01/03/1995SE |
| K940030 | Bisco CompositeEMA · Traditional | 02/04/1994SE |
| K934596 | Bisco Duo Link D/C Luting CompositeKLE · Traditional | 01/26/1994SE |
| K934247 | Bisco Universal Hybrid CompositeEBF · Traditional | 11/29/1993SE |
| K930405 | Bisco D/C Core CompositeEBF · Traditional | 08/24/1993SE |
| K932379 | All-Bond(R) Jr.KLE · Traditional | 07/22/1993SE |
| K926238 | Bisco Porcelain Etching GelEIH · Traditional | 03/31/1993SE |
| K924151 | Bisco D/C ResinomerEBF · Traditional | 12/28/1992SE |
| K923842 | Bisco Universal BOND-3KLE · Traditional | 09/29/1992SE |
| K921439 | Bisco Core PasteEBF · Traditional | 05/11/1992SE |
| K915668 | Bisco Cavity CleanserEBF · Traditional | 04/21/1992SE |
| K910860 | All-Bond 2KLE · Traditional | 04/29/1991SE |
| K910628 | All Bond Liner-FKLE · Traditional | 03/29/1991SE |
| K897020 | All-Bond Dentin Bonding SystemKLE · Traditional | 03/14/1990SE |
| K883465 | Ortho-SealDYH · Traditional | 10/12/1988SE |
| K882915 | FortifyEBF · Traditional | 08/12/1988SE |
| K875313 | Porcelain Veneer Resin Cement W/Dual Cure CatalystEBF · Traditional | 03/10/1988SE |
| K875256 | BiscolorEBF · Traditional | 02/26/1988SE |
| K874557 | Bisco Porcelain Repair KitEBC · Traditional | 01/28/1988SE |
| K874556 | Bisco Pit and Fissure SealantEBC · Traditional | 01/28/1988SE |
| K861148 | Bisco's Porcelain Veneer SystemEBF · Traditional | 04/30/1986SE |
| K853002 | Bisfil-Ii(Chemical Curable Posterior/Anterior)EBF · Traditional | 08/16/1985SE |
| K853001 | Bisfil-M(Light Curable Anterior Composite)EBF · Traditional | 08/16/1985SE |
| K842087 | Bisfil-I Light Curable Posterior CompoEBF · Traditional | 07/12/1984SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1697-2008 | Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is…During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive… | 04/28/2008Terminated |
| Z-1696-2008 | Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The…During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive… | 04/28/2008Terminated |