Company ยท US
Bisco, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2025. Name variants (Inc, Corp, punctuation) are merged.
88510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 30 |
| KLE | Agent, Tooth Bonding, Resin | 18 |
| EMA | Cement, Dental | 11 |
| EBD | Coating, Filling Material, Resin | 6 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 4 |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 2 |
| LBH | Varnish, Cavity | 2 |
| EIH | Powder, Porcelain | 1 |
| ELR | Post, Root Canal | 1 |
| KIF | Resin, Root Canal Filling | 1 |
| KOJ | Airbrush | 1 |
| PME | External Cleaning Solution | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2025 | K250156 | Choice 2 DC Bisco, Inc. | EMA |
| Dec 17, 2024 | K242816 | Quantium Bisco, Inc. | EBF |
| Mar 17, 2020 | K192007 | TheraBase, TheraBase Ca Bisco, Inc. | EMA |
| Nov 18, 2019 | K182917 | FluoroCal Bisco, Inc. | LBH |
| Apr 5, 2018 | K180344 | TheraCal DC Bisco, Inc. | EJK |
| Aug 4, 2017 | K171147 | REVEAL Bulk Bisco, Inc. | EBF |
| May 23, 2017 | K162598 | HAPI Seal Bisco, Inc. | EBC |
| Apr 14, 2017 | K163171 | CeraClean Bisco, Inc. | PME |
| Sep 9, 2016 | K161051 | All-Bond Universal w/BAC (not finalized) Bisco, Inc. | KLE |
| Jul 29, 2016 | K161256 | TheraCem Bisco, Inc. | EMA |
| Aug 4, 2015 | K143292 | TheraCal DC Bisco, Inc. | EJK |
| Sep 12, 2014 | K141439 | ORTHODONTIC ACRYLIC (NOT FINALIZED) Bisco, Inc. | EBI |
| Apr 11, 2014 | K131734 | ALL-BOND UNIVERSAL SC (NOT FINALIZED) Bisco, Inc. | KLE |
| Jun 3, 2013 | K123653 | SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) Bisco, Inc. | LBH |
| Feb 7, 2012 | K113401 | ORTHO-1(NOT FINALIZED) Bisco, Inc. | DYH |
| Nov 17, 2011 | K112118 | DREAMBOND Bisco, Inc. | KLE |
| May 25, 2011 | K103514 | PRO-V COAT Bisco, Inc. | EBG |
| Oct 29, 2010 | K102844 | ALL-BOUND 3 Bisco, Inc. | KLE |
| Oct 8, 2010 | K101787 | DUOLINK II Bisco, Inc. | EMA |
| Aug 26, 2010 | K101485 | ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E Bisco, Inc. | KLE |
| Feb 17, 2010 | K093470 | CORE-FLO D/C Bisco, Inc. | EBF |
| Aug 28, 2009 | K091705 | PRIMER PLUS Bisco, Inc. | KLE |
| Sep 25, 2008 | K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 Bisco, Inc. | EMA |
| Feb 14, 2008 | K073263 | PRO-V Bisco, Inc. | EBG |
| Jan 19, 2007 | K063780 | ACE BOND SE Bisco, Inc. | KLE |
| Dec 8, 2006 | K063237 | THERACAL LC Bisco, Inc. | EJK |
| May 15, 2006 | K060701 | BISCEM TRANSLUCENT, BISCEM OPAQUE Bisco, Inc. | EMA |
| Mar 29, 2006 | K052122 | BISCO LED Bisco, Inc. | EBZ |
| Aug 22, 2005 | K051999 | BISCOVER LED Bisco, Inc. | EBD |
| Apr 20, 2005 | K050647 | ALL-IN-ONE Bisco, Inc. | KLE |
| Feb 1, 2005 | K043168 | BISCOVER LV Bisco, Inc. | EBD |
| Feb 1, 2005 | K042804 | TESCERA OPAQUER POWDER/SCULPTING RESIN Bisco, Inc. | EBF |
| Mar 19, 2004 | K034024 | TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS Bisco, Inc. | EBI |
| Jan 16, 2004 | K033585 | DIAPEX Bisco, Inc. | KIF |
| Jan 16, 2004 | K033521 | BISBLOCK Bisco, Inc. | EJK |
| Jan 15, 2004 | K033472 | TESCERA U-BAR AND BARRELS Bisco, Inc. | EBI |
| Nov 4, 2003 | K032597 | BISCEM GI Bisco, Inc. | EMA |
| Jun 6, 2003 | K030951 | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P Bisco, Inc. | EBF |
| Apr 28, 2003 | K030585 | SCULPTING RESIN Bisco, Inc. | EBD |
| Feb 19, 2003 | K030354 | BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER Bisco, Inc. | EBD |
| Feb 6, 2003 | K024046 | TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P Bisco, Inc. | EBD |
| Aug 1, 2002 | K021503 | UNINHIBITED Bisco, Inc. | EBD |
| Jan 17, 2002 | K013519 | SIMPLE Bisco, Inc. | KLE |
| Sep 17, 2001 | K012032 | FIRST SPEP Bisco, Inc. | DYH |
| Sep 5, 2001 | K012180 | A-WEAR Bisco, Inc. | EBF |
| Jun 8, 2001 | K011159 | ONE-STEP PLUS Bisco, Inc. | EMA |
| Apr 5, 2001 | K010196 | TOTAL CURE Bisco, Inc. | EBF |
| Nov 28, 2000 | K003361 | RENEW LS-2 Bisco, Inc. | EBF |
| Nov 21, 2000 | K003317 | RENEW LS-1 Bisco, Inc. | EBF |
| Apr 12, 2000 | K000426 | VIP- VARIABLE INTENSITY POLYMERIZER Bisco, Inc. | EBZ |
Newest 50 of 88.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2008 | Bisco Inc Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix Terminated |
EMA | K060701 |
| Aug 25, 2008 | Bisco Inc Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to Terminated |
EMA | K060701 |