Cement, Dental
Regulation 872.3275
10510(k)s in 12 months (509 all time)
0recalls in 12 months (16 all time)
13recalls that name a 510(k)
Top companies in EMA
| Company | 510(k)s | Recalls |
|---|---|---|
| GC America, Inc. | 30 | 0 |
| Voco GmbH | 26 | 2 |
| Shofu Dental Corp. | 24 | 0 |
| Dentsply Intl. | 19 | 0 |
| Pulpdent Corp. | 14 | 0 |
| Sybron Dental Specialties | 14 | 0 |
| 3M Company | 12 | 0 |
| Bisco, Inc. | 9 | 2 |
| Espe GmbH (Us) | 10 | 0 |
| Coltene/Whaledent AG | 9 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 5, 1994 | K933139 | 3M VITREMER LUTING CEMENT 3M Company | EMA |
| Dec 13, 1993 | K934184 | FASTFIL Scientific Pharmaceuticals, Inc. | EMA |
| Nov 1, 1993 | K933554 | JEDENTAL ZINC CEMENT IMPROVED Jedental Co., Inc. | EMA |
| Nov 1, 1993 | K933543 | ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) Jedental Co., Inc. | EMA |
| Oct 20, 1993 | K933459 | RESIMENT WITH FLUORIDE J.L. Blosser, Inc. | EMA |
| Jul 8, 1993 | K931229 | VARIGLASS VLC GLASS IONOMER Dentsply Intl. | EMA |
| Jul 8, 1993 | K925207 | GLASS IONOMER CEMENT Milton Hodosh, M.D. | EMA |
| Jul 8, 1993 | K924132 | E.Z. TEMEP, TEMPORARY FILLING MATERIAL Cosmedent, Inc. | EMA |
| Jun 18, 1993 | K925027 | PHOTAC-FIL APLICAP Espe GmbH (Us), DE | EMA |
| Jun 17, 1993 | K930116 | LCL 8 Voco GmbH | EMA |
| May 27, 1993 | K931084 | TEMPIT Centrix, Inc. | EMA |
| Apr 12, 1993 | K923473 | MULTIPURPOSE RESIN CEMENT Dentsply Intl. | EMA |
| Apr 8, 1993 | K930455 | CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER Voco GmbH | EMA |
| Apr 8, 1993 | K926492 | ARGION DENTAL CEMENT Voco GmbH | EMA |
| Mar 31, 1993 | K926458 | BIFIX DENTAL CEMENT Voco GmbH | EMA |
| Feb 17, 1993 | K925713 | VITA CEREC DUO CEMENT Vident | EMA |
| Dec 23, 1992 | K925032 | 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM 3M Company | EMA |
| Nov 4, 1992 | K921173 | TYPE 1 DENTAL CEMENT Centrix, Inc. | EMA |
| Sep 9, 1992 | K923328 | VENEER CEMENT Dentsply Intl. | EMA |
| Aug 10, 1992 | K922853 | AQUA IONOFIL Voco GmbH | EMA |
| Aug 10, 1992 | K922638 | TEMPIT-E Centrix, Inc. | EMA |
| Aug 5, 1992 | K922854 | AQUA MERON Voco GmbH | EMA |
| Mar 25, 1992 | K915666 | AMALCODEN Mion International Corp. | EMA |
| Mar 20, 1992 | K914318 | GLASS IONOMER CEMENT Confi-Dental Products Co. | EMA |
| Feb 25, 1992 | K915619 | IONOFIL/LONOFIL MOLAR Voco GmbH | EMA |
| Feb 25, 1992 | K915618 | PROVICOL Voco GmbH | EMA |
| Feb 3, 1992 | K915467 | CIMPAT S DENTAL CEMENT Specialites Septodont | EMA |
| Feb 3, 1992 | K914612 | MERON DENTAL CEMENT Voco GmbH | EMA |
| Jan 14, 1992 | K915005 | PHOTAC-BOND APLICAP, MODIFICATION Espe GmbH (Us), DE | EMA |
| Jan 3, 1992 | K911061 | ESPE KETAC-ENDO APLICAP H.A. Opotow Consulting | EMA |
| Dec 27, 1991 | K914324 | CAVITY VARNISH PRODUCT Confi-Dental Products Co. | EMA |
| Nov 19, 1991 | K913519 | SUMO GLASS IONOMER CEMENT Ortho Source | EMA |
| Oct 30, 1991 | K913884 | FUJI II LC G-C Intl. Corp. | EMA |
| Oct 21, 1991 | K914073 | F21(R) DENTAL CEMENT Voco GmbH | EMA |
| Oct 17, 1991 | K913836 | VLC GLASS IONOMER Dentsply Intl. | EMA |
| Oct 9, 1991 | K913572 | AUTOPACK NON-EUGENOL PERIODONTAL DRESSING Specialites Septodont | EMA |
| Jul 30, 1991 | K912497 | IONOBOND Voco GmbH | EMA |
| Jun 17, 1991 | K911842 | 3M LUTING CEMENT, PASTE A AND B 3M Company | EMA |
| Apr 29, 1991 | K910719 | SILICOATER MD Kulzer, Inc. | EMA |
| Apr 3, 1991 | K910424 | TEETHMATE-F Kuraray Co. | EMA |
| Dec 27, 1990 | K904034 | TEMPORARY DENTAL CEMENT Medical Device Inspection Co., Inc. | EMA |
| Nov 9, 1990 | K904024 | CEMPER Scientific Pharmaceuticals, Inc. | EMA |
| Sep 19, 1990 | K901524 | CHEMFIL II CAPS Dentsply Intl. | EMA |
| Aug 28, 1990 | K902817 | SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST Confi-Dental Products Co. | EMA |
| Aug 28, 1990 | K902392 | COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL Coltene, Inc. | EMA |
| Aug 3, 1990 | K902078 | ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY. Crx Medical, Inc. | EMA |
| Aug 1, 1990 | K902894 | POST CEMENT (DENTAL COMPOSITE) Medical Device Inspection Co., Inc. | EMA |
| Jul 13, 1990 | K902052 | AHYDRON DENTAL CLEANING AGENT Ivoclar North America, Inc. | EMA |
| Jul 10, 1990 | K902635 | MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS Confi-Dental Products Co. | EMA |
| Jul 9, 1990 | K901082 | CYANODONT DENTAL CEMENT Specialites Septodont | EMA |
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