GC America, Inc.
128 FDA 510(k) clearances · Manufacturer
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cytrans™ Elashield (K253317) | GC America, Inc. | 2026-07-06 |
| SRGC-06 (K261246) | GC America, Inc. | 2026-06-18 |
| G-CEM UNIVERSAL (K254109) | GC America, Inc. | 2026-05-18 |
| G-Bond Universal (K251124) | GC America, Inc. | 2025-10-02 |
| EQUIA LC ONE (K250953) | GC America, Inc. | 2025-09-19 |
| G aenial Universal Injectable II (K251946) | GC America, Inc. | 2025-08-29 |
| G-CEM ONE (K200798) | GC America, Inc. | 2020-11-24 |
| BZF-29 (K200682) | GC America, Inc. | 2020-10-02 |
| Cytrans Granules (K192597) | GC America, Inc. | 2020-08-17 |
| GC Temp Print (K193113) | GC America, Inc. | 2020-07-09 |
| GC Fuji Triage EP (K193484) | GC America, Inc. | 2020-07-02 |
| everX Flow (K192260) | GC America, Inc. | 2019-11-22 |
| GC FujiCEM 2 (Improved) (K182854) | GC America, Inc. | 2019-07-11 |
| GC Acrylic Primer (K180917) | GC America, Inc. | 2018-11-20 |
| AIM2 (K181011) | GC America, Inc. | 2018-07-12 |
| GC Fuji Direct (K172382) | GC America, Inc. | 2018-04-02 |
| NMF004A (K173500) | GC America, Inc. | 2018-03-08 |
| Initial LiSi Block (K153130) | GC America, Inc. | 2016-09-13 |
| Gradia Plus (K153325) | GC America, Inc. | 2016-07-12 |
| G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (K153231) | GC America, Inc. | 2016-07-06 |
| Initial LiSi Press (K153136) | GC America, Inc. | 2016-06-30 |
| everX Posterior (K153127) | GC America, Inc. | 2016-05-20 |
| MSCB-001 (K152274) | GC America, Inc. | 2016-03-25 |
| GC Reline II (K153253) | GC America, Inc. | 2016-03-03 |
| G-Fix (K151541) | GC America, Inc. | 2015-10-09 |
| G-Premio BOND (K143140) | GC America, Inc. | 2015-04-20 |
| MSN-006 (K141562) | GC America, Inc. | 2014-09-05 |
| HTFX-222 (K133182) | GC America, Inc. | 2014-04-09 |
| CERASMART (K133824) | GC America, Inc. | 2014-03-14 |
| OPTIGLAZE COLOR (K133836) | GC America, Inc. | 2014-03-06 |
| MFP-051 (K123631) | GC America, Inc. | 2013-07-23 |
| GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV (K113816) | GC America, Inc. | 2013-01-30 |
| GAM-200 (K120243) | GC America, Inc. | 2012-06-27 |
| GC BLUE SILICONE (K120521) | GC America, Inc. | 2012-05-10 |
| GC AADVA BO AC ABUTMENTS (K103234) | GC America, Inc. | 2011-06-30 |
| FIT CHECKER ADVANCED (K110871) | GC America, Inc. | 2011-06-17 |
| GC ORAL MOISTURIZING GEL (K101346) | GC America, Inc. | 2011-01-27 |
| MI VARNISH (K102808) | GC America, Inc. | 2010-12-22 |
| GC AADVA IMPLANT SYSTEM (K093749) | GC America, Inc. | 2010-12-06 |
| GC FUJI TEMP (K101420) | GC America, Inc. | 2010-09-17 |
| AADVA ZR COLORING LIQUID (K092020) | GC America, Inc. | 2009-09-29 |
| GCUC-505 (K091388) | GC America, Inc. | 2009-07-22 |
| EQUIA (K091106) | GC America, Inc. | 2009-06-17 |
| MI FLOW (GCUC-450) (K090747) | GC America, Inc. | 2009-06-10 |
| GC AADVA ZR DISK (K082740) | GC America, Inc. | 2008-11-26 |
| GDLS-200 (K082434) | GC America, Inc. | 2008-11-14 |
| GRADIA CORE (K082171) | GC America, Inc. | 2008-10-30 |
| G-BOND PLUS (K082768) | GC America, Inc. | 2008-10-21 |
| GC OPB-100 (K080724) | GC America, Inc. | 2008-06-11 |
| GRADIA FORTE (K080478) | GC America, Inc. | 2008-06-05 |
| UNIFAST III (K073106) | GC America, Inc. | 2008-04-11 |
| JNE IMPLANT SYSTEM (K072425) | GC America, Inc. | 2008-03-10 |
| GC GAM-100 (K073283) | GC America, Inc. | 2008-02-20 |
| GC MODELS OPA-100 AND JC-50 (K073588) | GC America, Inc. | 2008-02-15 |
| GC AADVA ABUTMENT (K072100) | GC America, Inc. | 2008-02-14 |
| GC-ZIRCONIA (K071674) | GC America, Inc. | 2007-08-09 |
| GVC-100 (K070840) | GC America, Inc. | 2007-05-15 |
| GC MI PASTE PLUS (K070854) | GC America, Inc. | 2007-04-12 |
| COE SOFT (K070697) | GC America, Inc. | 2007-03-29 |
| COE COMFORT (K070698) | GC America, Inc. | 2007-03-29 |
| GRADIA DIRECT X (K070190) | GC America, Inc. | 2007-03-12 |
| GC FUJI IX GP EXTRA (K070319) | GC America, Inc. | 2007-02-26 |
| GC XLC-100 CAPSULE (K061535) | GC America, Inc. | 2006-07-14 |
| G-COAT (K052462) | GC America, Inc. | 2005-10-20 |
| GC FUJI FIL LC (K051427) | GC America, Inc. | 2005-08-22 |
| NATURE-CRYL HI PLUS (K051358) | GC America, Inc. | 2005-07-07 |
| FUSION PUTTY TYPE (K043493) | GC America, Inc. | 2005-03-04 |
| G-LIGHT (K050059) | GC America, Inc. | 2005-02-03 |
| FUSION FAST (K043471) | GC America, Inc. | 2005-01-27 |
| GC TION GINGIVAL PROTECTOR (K043301) | GC America, Inc. | 2005-01-25 |
| GRADIA DIRECT LOFLO (K042348) | GC America, Inc. | 2004-11-18 |
| MI PASTE (K042200) | GC America, Inc. | 2004-10-20 |
| G-BOND (K041471) | GC America, Inc. | 2004-06-29 |
| GC FUSION (K041398) | GC America, Inc. | 2004-06-25 |
| GC INITIAL MC, AL AND LF (K040567) | GC America, Inc. | 2004-04-22 |
| GRADIA GUM (K033808) | GC America, Inc. | 2004-02-02 |
| FIT CHECKER II (K032289) | GC America, Inc. | 2003-10-20 |
| GRADIA DIRECT (K023814) | GC America, Inc. | 2003-01-30 |
| EXAJET (K023751) | GC America, Inc. | 2003-01-22 |
| TEMPORARY CEMENT-DC010002 (K023727) | GC America, Inc. | 2003-01-16 |
| ISO FUNCTIONAL (K022430) | GC America, Inc. | 2002-10-18 |
| GC ELITE CEMENT 100 (K021038) | GC America, Inc. | 2002-05-03 |
| GC FUJI ORTHO BAND PASTE PAK (K020578) | GC America, Inc. | 2002-04-26 |
| UNIFIL FLOW (K020342) | GC America, Inc. | 2002-03-28 |
| GC FUJI LINING LC PASTE PAK (K020117) | GC America, Inc. | 2002-02-28 |
| UNIFIL BOND (K013997) | GC America, Inc. | 2002-02-20 |
| FUJI VII CAPSULE (K013198) | GC America, Inc. | 2001-10-29 |
| REVOTEK LC (K012542) | GC America, Inc. | 2001-10-16 |
| GC E-LIGHT (K012134) | GC America, Inc. | 2001-08-07 |
| PATTERN RESIN (K003817) | GC America, Inc. | 2001-01-16 |
| LINKMAX (K001823) | GC America, Inc. | 2000-08-16 |
| GC FUJICEM (K001730) | GC America, Inc. | 2000-07-17 |
| GRADIA (K001518) | GC America, Inc. | 2000-07-05 |
| AROMA FINE (NORMAL AND FAST SET) (K994077) | GC America, Inc. | 2000-01-27 |
| FUJI II LC CAPSULE (K993973) | GC America, Inc. | 2000-01-11 |
| ACRON MC MODIFICATION (K991774) | GC America, Inc. | 1999-07-09 |
| GC RELINE SOFT/EXTRA SOFT (K990736) | GC America, Inc. | 1999-05-28 |
| GC UNIFAST TRAD (K984365) | GC America, Inc. | 1999-02-25 |
| MIRACLE MIX POWDER/LIQUID (K984505) | GC America, Inc. | 1999-02-04 |
| GC RELINE (K982695) | GC America, Inc. | 1998-10-19 |
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