FDA 510(k) Applications for Medical Device Product Code "EMA"
(Cement, Dental)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K973961 | 3M COMPANY | 3M DENT SYSTEM II PLUS | 12/17/1997 |
| K170330 | 3M Company | 3M Protemp Cement Temporary Dental Cement | 02/06/2017 |
| K002452 | 3M COMPANY | 3M RELY X VENEER CEMENT TRY-IN PASTER | 09/28/2000 |
| K962065 | 3M COMPANY | 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE | 07/18/1996 |
| K011200 | 3M COMPANY | GILB, MODEL 8010 | 06/14/2001 |
| K052235 | 3M COMPANY | LCR | 09/27/2005 |
| K022476 | 3M COMPANY | RELYX RMGIP | 08/02/2002 |
| K153174 | 3M DEUTSCHLAND GMBH | Ketac Universal Aplicap | 04/13/2016 |
| K192992 | 3M Deutschland GMBH | Suglue 3 | 11/05/2019 |
| K110508 | 3M ESPE AG | SUGLUE-10 | 06/03/2011 |
| K100756 | 3M ESPE AG DENTAL PRODUCTS | MALTA | 06/02/2010 |
| K020256 | 3M ESPE AG DENTAL PRODUCTS | UNICEM | 03/25/2002 |
| K094007 | 3M ESPE AG DENTAL PRODUCTS | UNICEM | 04/08/2010 |
| K100908 | 3M ESPE AG DENTAL PRODUCTS | UNICEM HM | 06/22/2010 |
| K191122 | 3M ESPE Dental Products | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | 05/29/2019 |
| K073395 | 3M ESPE DENTAL PRODUCTS | GILB-2, GLASS IONOMER PROTECTIVE COATING | 01/17/2008 |
| K111185 | 3M ESPE DENTAL PRODUCTS | RELYX LUTING PLUS AUTOMIX | 05/05/2011 |
| K062292 | 3M ESPE DENTAL PRODUCTS | UNICEM | 10/25/2006 |
| K991974 | AB ARDENT | FUTURA GLASS IONOMER SILVER REINFORCED | 09/17/1999 |
| K020376 | ADVANCED HEALTHCARE LTD. | AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE | 04/09/2002 |
| K023981 | ADVANCED HEALTHCARE LTD. | AHL GENERIC GLASS IONOMER LUTING CEMENT | 01/31/2003 |
| K024287 | ADVANCED HEALTHCARE LTD. | FIXOBRIDGE 3-CEMENT | 03/21/2003 |
| K972485 | ARENT, FOX, KINTNER, PLOTKIN & KAHN | CIMPAT N | 09/08/1997 |
| K032597 | BISCO, INC. | BISCEM GI | 11/04/2003 |
| K060701 | BISCO, INC. | BISCEM TRANSLUCENT, BISCEM OPAQUE | 05/15/2006 |
| K082449 | BISCO, INC. | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 | 09/25/2008 |
| K101787 | BISCO, INC. | DUOLINK II | 10/08/2010 |
| K011159 | BISCO, INC. | ONE-STEP PLUS | 06/08/2001 |
| K192007 | Bisco, Inc. | TheraBase, TheraBase Ca | 03/17/2020 |
| K161256 | BISCO, INC. | TheraCem | 07/29/2016 |
| K974097 | BLACKLOCK MEDICAL PRODUCTS, INC. | PERIACRYL | 04/09/1998 |
| K003791 | CAVEX HOLLAND B.V. | CAVEX TEMPORARY CEMENT | 01/23/2001 |
| K980568 | CENTRIX, INC. | JUMBO GLASS IONOMER CEMENT | 04/30/1998 |
| K982665 | CENTRIX, INC. | JUMBO SILVER-REINFORCED GLASS IONOMER | 09/08/1998 |
| K980159 | CLOSURE MEDICAL CORP. | OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 | 04/09/1998 |
| K072604 | COLTENE/WHALEDENT AG | DUO TEMP | 11/16/2007 |
| K160800 | COLTENE/WHALEDENT AG | DuoCem | 11/16/2016 |
| K053040 | COLTENE/WHALEDENT AG | PARACEM UNIVERSAL DC | 11/09/2005 |
| K121621 | COLTENE/WHALEDENT AG | SOLOCEM | 01/08/2013 |
| K083304 | COLTENE/WHALEDENT AG | TEMPOSIL 2 | 02/06/2009 |
| K050426 | COLTENE/WHALEDENT AG | TEMPOSIL, MODEL 6720 | 03/18/2005 |
| K031752 | COLTENE/WHALEDENT INC. | COLTOSOL F | 08/05/2003 |
| K993710 | COLTENE/WHALEDENT INC. | MODIFICATION OF PARAPOST CEMENT | 12/21/1999 |
| K031494 | COOLEY & COOLEY, LTD. | DOC'S BEST WHITE COPPER CEMENT | 11/12/2003 |
| K122974 | CROWN DELTA CORP. | TRYOUT-VPS HOLDING PASTE | 05/17/2013 |
| K073101 | DENALI CORPORATION | AURAVENEER CEMENT | 01/17/2008 |
| K132393 | DENALI CORPORATION | CERCOM II CEMENT | 03/14/2014 |
| K141503 | DENALI CORPORATION | DENALI 501CEMENT | 11/10/2014 |
| K083398 | DENALI R&D CORPORATION | CERCOM CEMENT | 01/26/2009 |
| K183465 | Dentscare LTDA | Allcem, Allcem Core | 11/02/2019 |
| K101493 | DENTSPLY INTERNATIONAL, INC. | ADVANCED GLASS IONOMER (K-130) RESTORATIVE | 08/19/2010 |
| K073173 | DENTSPLY INTERNTIONAL | SELF-ADHESIVE RESIN CEMENT | 01/23/2008 |
| K974140 | DENTSPLY INTL. | ADHESIVE HYBRID IONOMER CEMENT | 01/05/1998 |
| K040906 | DENTSPLY INTL. | CALIBRA CEMENT | 06/16/2004 |
| K003921 | DENTSPLY INTL. | DYRACT CEM LCI COMPOMER | 01/24/2001 |
| K041272 | DENTSPLY INTL. | DYRACT CEM PLUS CEMENT | 10/18/2004 |
| K981965 | DENTSPLY INTL. | FLOWABLE COMPOSITE | 07/10/1998 |
| K040895 | DENTSPLY INTL. | INTEGRITY TEMPORARY CEMENT | 05/21/2004 |
| K192530 | Dentsply Sirona | Surefil one Self-adhesive Composite Hybrid | 01/23/2020 |
| K100247 | DETAX GMBH & CO. KG | DETAX IMPLANTLINK SEMI | 07/23/2010 |
| K123824 | DFL INDUSTRIA E COMERCIO S.A. | VITRO FIL LC | 02/21/2013 |
| K123826 | DFL INDUSTRIA E COMERCIO S.A. | VITRO MOLAR | 02/14/2013 |
| K231552 | Diadent Group International | Dia-Cem | 07/28/2023 |
| K991172 | DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH | IONOSIT BOND | 05/17/1999 |
| K213201 | DMG Chemisch-Pharmazeutische Fabrik GmbH | DeltaFil, DeltaFil Conditioner | 06/01/2022 |
| K012316 | DMG USA, INC. | PERMACEM / PERMACEM DUAL | 08/23/2001 |
| K093338 | DMG USA, INC. | SELF ADHESIVE COMPOSITE LUTING CEMENT | 02/12/2010 |
| K160443 | DMG USA, INC. | TempoCem Clear | 09/30/2016 |
| K023649 | DMG USA, INC. | VITIQUE SYSTEM | 01/17/2003 |
| K100510 | DOXA AB | CERAMIR CROWN & BRIDGE | 03/25/2010 |
| K113040 | DOXA DENTAL AB | CERAMIR CROWN & BRIDGE | 12/28/2011 |
| K201937 | Doxa Dental AB | Ceramir Restore QuikCap | 11/13/2020 |
| K081405 | DOXA DENTAL AB | XERACEM | 08/21/2008 |
| K973636 | DR. HOWARD MARTIN, P.A. | MCS-MEDICATED CANAL SEALER | 07/27/1998 |
| K002793 | ESPE DENTAL AG | KETAC CEM U | 09/26/2000 |
| K984248 | ESPE DENTAL AG | PROCEM | 01/08/1999 |
| K974458 | ESPE DENTAL-MEDIZIN GMBH & CO.KG. | COMPOLUTE APLICAP | 02/02/1998 |
| K963737 | ESPE GMBH & CO. KG. | HYCEM APLICAP | 11/15/1996 |
| K973262 | ESPE GMBH & CO. KG. | KETAC-FIL APLICAP PLUS | 11/17/1997 |
| K960954 | ESPE GMBH & CO. KG. | KETAC-MOLAR APLICAP | 05/16/1996 |
| K152691 | ESSENTIAL DENTAL SYSTEMS, INC | EDS Universal Cement | 02/25/2016 |
| K101504 | ESSENTIAL DENTAL SYSTEMS, INC. | TI-CORE FLOW | 10/29/2010 |
| K142446 | EXACTA DENTAL DIRECT, INC | Fixtemp Cement | 06/04/2015 |
| K011520 | FIRST SCIENTIFIC LIMITED | RESTORE-X | 07/23/2001 |
| K970775 | FOREMOST DENTAL MFG., INC. | TEMPO CEM (MULTIPLE) | 06/03/1997 |
| K970774 | FOREMOST DENTAL MFG., INC. | TEMPOCEM NE (MULTIPLE) | 06/03/1997 |
| K152652 | GAIA DENTAL PRODUCTS, INC. | PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement | 04/05/2016 |
| K200798 | GC America Inc. | G-CEM ONE | 11/24/2020 |
| K120243 | GC AMERICA INC. | GAM-200 | 06/27/2012 |
| K172382 | GC America Inc. | GC Fuji Direct | 04/02/2018 |
| K193484 | GC America Inc. | GC Fuji Triage EP | 07/02/2020 |
| K182854 | GC America Inc. | GC FujiCEM 2 (Improved) | 07/11/2019 |
| K091106 | GC AMERICA, INC. | EQUIA | 06/17/2009 |
| K980695 | GC AMERICA, INC. | FUJI I | 04/13/1998 |
| K980682 | GC AMERICA, INC. | FUJI II | 04/03/1998 |
| K961584 | GC AMERICA, INC. | FUJI II LC (IMPROVED) | 05/24/1996 |
| K961448 | GC AMERICA, INC. | FUJI IX GP | 07/08/1996 |
| K013198 | GC AMERICA, INC. | FUJI VII CAPSULE | 10/29/2001 |
| K153231 | GC AMERICA, INC. | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | 07/06/2016 |
| K021038 | GC AMERICA, INC. | GC ELITE CEMENT 100 | 05/03/2002 |
| K070319 | GC AMERICA, INC. | GC FUJI IX GP EXTRA | 02/26/2007 |
| K051427 | GC AMERICA, INC. | GC FUJI FIL LC | 08/22/2005 |
| K020117 | GC AMERICA, INC. | GC FUJI LINING LC PASTE PAK | 02/28/2002 |
| K101420 | GC AMERICA, INC. | GC FUJI TEMP | 09/17/2010 |
| K001730 | GC AMERICA, INC. | GC FUJICEM | 07/17/2000 |
| K073283 | GC AMERICA, INC. | GC GAM-100 | 02/20/2008 |
| K061535 | GC AMERICA, INC. | GC XLC-100 CAPSULE | 07/14/2006 |
| K070840 | GC AMERICA, INC. | GVC-100 | 05/15/2007 |
| K001823 | GC AMERICA, INC. | LINKMAX | 08/16/2000 |
| K981370 | GC AMERICA, INC. | MIRACLE MIX CAPSULE | 06/01/1998 |
| K984505 | GC AMERICA, INC. | MIRACLE MIX POWDER/LIQUID | 02/04/1999 |
| K023727 | GC AMERICA, INC. | TEMPORARY CEMENT-DC010002 | 01/16/2003 |
| K023888 | GLOBAL DENTAL PRODUCTS, INC. | CIMOFLUOR | 03/05/2003 |
| K013446 | GLUSTITCH, INC. | GLUSITE, MODEL GLU002 | 12/20/2001 |
| K071484 | GLUSTITCH, INC. | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 | 10/10/2007 |
| K050658 | HAGER WORLDWIDE, INC. | RESO-PAC PERIODONTAL DRESSING | 05/27/2005 |
| K983752 | HARRY J. BOSWORTH CO. | ALUMINA-ZINC OXIDE POWDERS F AND R | 12/10/1998 |
| K103585 | HARRY J. BOSWORTH CO. | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP | 03/04/2011 |
| K981618 | HARRY J. BOSWORTH CO. | LIQUID A | 07/28/1998 |
| K030727 | HEALEX PRODUCTS, INC. | POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT | 06/05/2003 |
| K010541 | HERAEUS KULZER, INC. | PREVISION CHEM | 07/31/2001 |
| K210473 | Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) | 11/02/2021 |
| K213609 | Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | NOVA RESIN dual cure, self adhesive resin cement | 08/09/2022 |
| K122549 | ITENA CLINICAL | DENTO TEMP | 04/26/2013 |
| K122551 | ITENA CLINICAL | PROVITEMP | 06/14/2013 |
| K121804 | ITENA CLINICAL | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | 04/19/2013 |
| K162960 | ITENA CLINICAL | TotalC-Ram | 03/14/2017 |
| K981335 | IVOCLAR NORTH AMERICA, INC. | ARISTON PHC LINER | 07/02/1998 |
| K980922 | IVOCLAR NORTH AMERICA, INC. | PROTEC CEM. | 04/30/1998 |
| K973397 | IVOCLAR NORTH AMERICA, INC. | SYNTAC SPRINT | 11/21/1997 |
| K003407 | IVOCLAR NORTH AMERICA, INC. | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) | 01/26/2001 |
| K962297 | IVOCLAR NORTH AMERICA, INC. | VIVAGLASS CEM | 06/26/1996 |
| K961910 | IVOCLAR NORTH AMERICA, INC. | VIVAGLASS FIL | 06/26/1996 |
| K130436 | IVOCLAR VIVADENT AG | MULTILINK HYBRID ABUTMENT CEMENT | 08/20/2013 |
| K120432 | IVOCLAR VIVADENT AG | TELIO CS CEM IMPLANT | 06/08/2012 |
| K032470 | IVOCLAR VIVADENT, INC. | MULTILINK | 11/05/2003 |
| K061781 | IVOCLAR VIVADENT, INC. | MULTILINK SPRINT | 09/05/2006 |
| K091019 | IVOCLAR VIVADENT, INC. | SPEEDCEM | 06/04/2009 |
| K042847 | IVOCLAR VIVADENT, INC. | SYSTEMP.CEM | 12/17/2004 |
| K042846 | IVOCLAR VIVADENT, INC. | SYSTEMP.LINK | 12/20/2004 |
| K000173 | JENERIC/PENTRON, INC. | CEMENT IT! UNIVERSAL C&B | 02/29/2000 |
| K990155 | KAY SEE DENTAL MFG. CO. | HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 | 02/25/1999 |
| K062519 | KERR CORPORATION | NEXUS 3 | 10/19/2006 |
| K123595 | KERR CORPORATION | NEXUS RMGI | 02/19/2013 |
| K191548 | Kerr Corporation | Nexus Universal Self-Cure | 10/11/2019 |
| K972844 | KERR DENTAL MATERIALS CENTER | TEMP BOND CLEAR | 10/03/1997 |
| K191527 | Kettenbach GmbH & Co. KG | Visalys CemCore, Visalys Cem Core Try In Paste | 11/08/2019 |
| K002322 | KURARAY AMERICA, INC. | MODIFICATION TO PANAVIA F | 09/18/2000 |
| K983361 | KURARAY AMERICA, INC. | PANAVIA F | 11/13/1998 |
| K980232 | KURARAY COMPANY, LTD. | CLEARFIL DC CEMENT | 02/24/1998 |
| K012735 | KURARAY MEDICAL INC. | CLEARFIL DC CEMENT | 09/14/2001 |
| K062410 | KURARAY MEDICAL INC. | CLEARFIL ESTHETIC CEMENT & DC BOND | 09/26/2006 |
| K081583 | KURARAY MEDICAL INC. | CLEARFIL SA CEMENT | 07/28/2008 |
| K012438 | KURARAY MEDICAL INC. | MODIFICATION TO PANAVIA 21 | 09/05/2001 |
| K012441 | KURARAY MEDICAL INC. | PANAVIA F | 09/06/2001 |
| K032455 | KURARAY MEDICAL INC. | PANAVIA F 2.0 | 11/07/2003 |
| K120379 | KURARAY MEDICAL INC. | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | 03/30/2012 |
| K120378 | KURARAY MEDICAL INC. | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S | 03/30/2012 |
| K142625 | KURARAY NORITAKE DENTAL INC. | PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) | 01/27/2015 |
| K183537 | Kuraray Noritake Dental Inc. | PANAVIA SA Cement Universal | 04/25/2019 |
| K210504 | Kuraray Noritake Dental Inc. | PANAVIA Veneer LC | 06/11/2021 |
| K142623 | KURARAY NORITAKE DENTAL, INC. | PANAVIA SA Cement Plus Handmix | 02/26/2015 |
| K150704 | KURARAY NORITAKE DENTAL, INC. | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Pa | 08/21/2015 |
| K960910 | LOCTITE CORP. | INDERMIL DENTAL | 03/28/1996 |
| K964773 | MAJESTIC DRUG CO., INC. | DENTEMP ONE STEP | 02/21/1997 |
| K982779 | MEDENTAL INTL. | MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 | 09/30/1998 |
| K980990 | MEDENTAL INTL. | POLYCARBOXYLATE CEMENT | 07/31/1998 |
| K983018 | MEDENTAL INTL. | ZINC PHOSPHATE CEMENT | 10/22/1998 |
| K993556 | MEDLOGIC GLOBAL CORP. | LIQUIBAND DENTAL | 01/03/2000 |
| K171449 | Meta Biomed Co., Ltd | Metacem | 05/15/2018 |
| K081913 | META BIOMED CO., LTD. | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER | 09/05/2008 |
| K062355 | MICERIUM S.P.A. | ENA CEM | 12/27/2006 |
| K032175 | MILTON HODOSH, M.D. | DESENS-IONOMER | 10/09/2003 |
| K971642 | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. | DENTALIS KEZ ENDODONITC SEALER | 07/24/1997 |
| K120283 | NOVOCOL, INC. | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | 07/31/2012 |
| K040343 | NOVOCOL, INC. | TEMP F | 08/03/2004 |
| K083516 | OROSCIENCE, INC. | PERIOGENIX | 02/20/2009 |
| K210259 | Parkell, Inc | Parkell Self-Adhesive Cement | 01/20/2022 |
| K960464 | PARKELL, INC. | C & B METABOND (MODIFICATION) | 02/26/1996 |
| K101044 | PARKELL, INC. | RETRIEVE IMPLANT CEMENT | 06/10/2010 |
| K073698 | PARKELL, INC. | SECURE | 03/19/2008 |
| K031212 | PARKELL, INC. | TEMPORARY RESIN CEMENT | 07/11/2003 |
| K990381 | PARKELL, INC. | TOTALBOND | 05/17/1999 |
| K060698 | PENTRON CLINICAL TECHNOLOGIES | CEMENT-IT ALL PURPOSE, MODEL N97 | 05/10/2006 |
| K081887 | PENTRON CLINICAL TECHNOLOGIES | LUTE-IT II VENEER CEMENT, MODEL NO6 | 08/29/2008 |
| K022150 | PENTRON CLINICAL TECHNOLOGIES | TRIONOMER | 08/21/2002 |
| K150601 | Premier Dental Company Products | Zeramic Adhesive Resin Cement | 07/22/2015 |
| K033309 | PREMIER DENTAL PRODUCTS CO. | PREMIER IMPLANT CEMENT, MODEL 3001450 | 01/26/2004 |
| K051866 | PREMIER DENTAL PRODUCTS CO. | PREMIER TEMPORARY CEMENT | 09/06/2005 |
| K042215 | PREMIER DENTAL PRODUCTS CO. | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | 09/21/2004 |
| K200555 | Prevest Denpro Limited | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | 05/13/2021 |
| K112574 | PRIME DENTAL MANUFACTURING, INC. | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | 01/23/2012 |
| K974014 | PULPDENT CORP. | PULPDENT DENTASTIC UNO | 12/17/1997 |
| K962747 | PULPDENT CORP. | PULPDENT ENDODONTIC POST CEMENT KIT | 09/30/1996 |
| K972445 | PULPDENT CORP. | PULPDENT OX-OUT | 10/02/1997 |
| K962383 | PULPDENT CORP. | PULPDENT RESILUTE II | 09/03/1996 |
| K020481 | PULPDENT CORPORATION | PULPDENT POST CEMENT | 04/17/2002 |
| K040236 | PULPDENT CORPORATION | PULPDENT VLC RESIN CEMENT | 04/20/2004 |
| K130223 | PULPDENT CORPORATION | RMGI FILL | 03/29/2013 |
| K123265 | PULPDENT CORPORATION | RMGI LOW VISCOSITY | 12/07/2012 |
| K010240 | RITE-DENT MANUFACTURING CORP. | POLYCARBOXYLATE (PCA) CEMENT | 03/27/2001 |
| K003427 | RITE-DENT MANUFACTURING CORP. | ZINC PHOSPHATE CEMENT | 01/24/2001 |
| K201790 | Rizhao HuGe Biomaterials Company, Ltd. | Dual Cure Resin Cement | 09/29/2020 |
| K081702 | S & C POLYMER GMBH | CARBOXYLATE CEM, PHOSPHATE CEM | 09/05/2008 |
| K011064 | S & C POLYMER GMBH | CLASSIC CEM | 05/17/2001 |
| K091735 | S & C POLYMER GMBH | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT | 09/25/2009 |
| K083766 | S & C POLYMER GMBH | PHOGLASS CEM | 03/02/2009 |
| K082115 | S & C POLYMER GMBH | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | 01/15/2009 |
| K973201 | S & C POLYMER GMBH | PROVI CEMENT | 06/05/1998 |
| K011431 | S & C POLYMER GMBH | RESIN CEM | 06/11/2001 |
| K972935 | S.S. WHITE MFG., LTD. | SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL | 01/29/1998 |
| K993324 | SCIENTIFIC PHARMACEUTICALS, INC. | CARBOCEM ZINC POLYCARBOXYLATE CEMENT | 11/09/1999 |
| K051952 | SCIENTIFIC PHARMACEUTICALS, INC. | EUGENONE | 09/07/2005 |
| K013555 | SCIENTIFIC PHARMACEUTICALS, INC. | SCI-PHARM POST SECURE | 01/23/2002 |
| K982913 | SCIENTIFIC PHARMACEUTICALS, INC. | ZINFOS ZINC PHOSPHATE CEMENT | 10/19/1998 |
| K214118 | SDI Limited | Riva Cem Automix | 08/30/2022 |
| K073043 | SDI LTD. | SET PP | 12/14/2007 |
| K160345 | SHANDONG HUGE DENTAL MATERIAL CORPORATION | Glass Ionomer Cement | 03/03/2017 |
| K161851 | SHANDONG HUGE DENTAL MATERIAL CORPORATION | Glass Ionomer Cement (Luting) | 10/31/2016 |
| K982461 | SHOFU DENTAL CORP. | GLASIONOMER CEMENT CX PLUS | 08/24/1998 |
| K031467 | SHOFU DENTAL CORP. | GLASIONOMER FX-II | 07/17/2003 |
| K971927 | SHOFU DENTAL CORP. | HI DENSE TC | 06/30/1997 |
| K002461 | SHOFU DENTAL CORP. | HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT | 09/26/2000 |
| K111855 | SHOFU DENTAL CORP. | HY-BOND RESIGLASS | 11/17/2011 |
| K080517 | SHOFU DENTAL CORP. | RESICEM | 06/11/2008 |
| K120159 | SHOFU DENTAL CORPORATION | BEAUTICEM SA | 06/18/2012 |
| K233161 | Shofu Dental Corporation | BeautiLink SA | 09/28/2023 |
| K222253 | Shofu Dental Corporation | GlasIonomer FX ULTRA | 09/22/2022 |
| K111685 | SHOFU DENTAL CORPORATION | IP TEMP CEMENT | 09/02/2011 |
| K112307 | SHOFU DENTAL CORPORATION | RESIGLASS PASTE | 03/28/2012 |
| K101869 | SILMET LTD. | PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) | 09/29/2010 |
| K062064 | SOUTHERN DENTAL INDUSTRIES, INC. | RIVA BOND LC | 11/09/2006 |
| K050870 | SOUTHERN DENTAL INDUSTRIES, INC. | RIVA LIGHT CURE | 06/03/2005 |
| K040393 | SOUTHERN DENTAL INDUSTRIES, INC. | RIVA LUTING | 04/30/2004 |
| K062065 | SOUTHERN DENTAL INDUSTRIES, INC. | RIVA LUTING PLUS | 11/15/2006 |
| K042452 | SOUTHERN DENTAL INDUSTRIES, INC. | RIVA SILVER | 12/07/2004 |
| K030516 | SOUTHERN DENTAL INDUSTRIES, INC. | RIVA-SELF CURE | 04/17/2003 |
| K051008 | SOUTHERN DENTAL INDUSTRIES, LTD. | SET | 06/15/2005 |
| K982773 | SPECIALITES SEPTODONT | QUICKSET LIQUID AND POWDER | 11/03/1998 |
| K214076 | SPIDENT CO., LTD. | EsCem | 12/19/2022 |
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