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 17, 2003 | K023649 | VITIQUE SYSTEM Dmg USA, Inc. | EMA |
| Jan 16, 2003 | K023727 | TEMPORARY CEMENT-DC010002 GC America, Inc. | EMA |
| Aug 21, 2002 | K022150 | TRIONOMER Pentron Clinical Technologies | EMA |
| Aug 2, 2002 | K022476 | RELYX RMGIP 3M Company | EMA |
| May 3, 2002 | K021038 | GC ELITE CEMENT 100 GC America, Inc. | EMA |
| Apr 17, 2002 | K020481 | PULPDENT POST CEMENT Pulpdent Corporation | EMA |
| Apr 9, 2002 | K020376 | AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE Advanced Healthcare , Ltd. | EMA |
| Mar 25, 2002 | K020256 | UNICEM 3M Espe AG Dental Products, DE | EMA |
| Feb 28, 2002 | K020117 | GC FUJI LINING LC PASTE PAK GC America, Inc. | EMA |
| Jan 23, 2002 | K013555 | SCI-PHARM POST SECURE Scientific Pharmaceuticals, Inc. | EMA |
| Jan 16, 2002 | K013609 | NEXUS 2 CLEAR Sybron Dental Specialties, Inc. | EMA |
| Dec 20, 2001 | K013446 | GLUSITE, MODEL GLU002 Glustitch, Inc., CA | EMA |
| Oct 29, 2001 | K013198 | FUJI VII CAPSULE GC America, Inc. | EMA |
| Oct 2, 2001 | K013008 | NEXUS 2 MODIFIED Sybron Dental Specialties, Inc. | EMA |
| Sep 14, 2001 | K012735 | CLEARFIL DC CEMENT Kuraray Medical, Inc. | EMA |
| Sep 6, 2001 | K012441 | PANAVIA F Kuraray Medical, Inc. | EMA |
| Sep 5, 2001 | K012438 | MODIFICATION TO PANAVIA 21 Kuraray Medical, Inc. | EMA |
| Sep 4, 2001 | K011854 | TOKUYAMA M-BOND Tokuyama America, Inc. | EMA |
| Aug 23, 2001 | K012316 | PERMACEM / PERMACEM DUAL Dmg USA, Inc. | EMA |
| Jul 31, 2001 | K011685 | BISTITE II DC Tokuyama America, Inc. | EMA |
| Jul 31, 2001 | K010541 | PREVISION CHEM Heraeus Kulzer, Inc. | EMA |
| Jul 23, 2001 | K011520 | RESTORE-X First Scientific Limited, GB | EMA |
| Jun 14, 2001 | K011200 | GILB, MODEL 8010 3M Company | EMA |
| Jun 11, 2001 | K011431 | RESIN CEM S & C Polymer GmbH, DE | EMA |
| Jun 8, 2001 | K011159 | ONE-STEP PLUS Bisco, Inc. | EMA |
| May 17, 2001 | K011064 | CLASSIC CEM S & C Polymer GmbH, DE | EMA |
| Mar 27, 2001 | K010240 | POLYCARBOXYLATE (PCA) CEMENT Rite-Dent Manufacturing Corp. | EMA |
| Jan 26, 2001 | K003407 | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) Ivoclar North America, Inc. | EMA |
| Jan 24, 2001 | K003921 | DYRACT CEM LCI COMPOMER Dentsply Intl. | EMA |
| Jan 24, 2001 | K003427 | ZINC PHOSPHATE CEMENT Rite-Dent Manufacturing Corp. | EMA |
| Jan 23, 2001 | K003791 | CAVEX TEMPORARY CEMENT Cavex Holland BV, NL | EMA |
| Jan 4, 2001 | K003658 | TEMP-BOND NE 2 Sybron Dental Specialties, Inc. | EMA |
| Nov 15, 2000 | K002843 | SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 Sultan Chemists, Inc. | EMA |
| Sep 28, 2000 | K002452 | 3M RELY X VENEER CEMENT TRY-IN PASTER 3M Company | EMA |
| Sep 26, 2000 | K002793 | KETAC CEM U Espe Dental AG, DE | EMA |
| Sep 26, 2000 | K002461 | HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT Shofu Dental Corp. | EMA |
| Sep 18, 2000 | K002322 | MODIFICATION TO PANAVIA F Kuraray America, Inc. | EMA |
| Aug 16, 2000 | K001823 | LINKMAX GC America, Inc. | EMA |
| Jul 17, 2000 | K001730 | GC FUJICEM GC America, Inc. | EMA |
| Feb 29, 2000 | K000173 | CEMENT IT! UNIVERSAL C&B Jeneric/Pentron, Inc. | EMA |
| Feb 2, 2000 | K994261 | ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT Ultradent Products, Inc. | EMA |
| Jan 3, 2000 | K993556 | LIQUIBAND DENTAL Medlogic Global Corp. | EMA |
| Dec 21, 1999 | K993710 | MODIFICATION OF PARAPOST CEMENT Coltene/Whaledent, Inc. | EMA |
| Nov 9, 1999 | K993324 | CARBOCEM ZINC POLYCARBOXYLATE CEMENT Scientific Pharmaceuticals, Inc. | EMA |
| Sep 17, 1999 | K991974 | FUTURA GLASS IONOMER SILVER REINFORCED Ab Ardent | EMA |
| Aug 18, 1999 | K992160 | NEXUS 2 Sybron Dental Specialties, Inc. | EMA |
| Jul 7, 1999 | K991711 | BISTITE II SC Tokuyama America, Inc. | EMA |
| May 17, 1999 | K991172 | IONOSIT BOND Dmg Chemisch Pharmazeutische Fabrik GmbH | EMA |
| May 17, 1999 | K990381 | TOTALBOND Parkell, Inc. | EMA |
| Feb 25, 1999 | K990155 | HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 Kay See Dental Mfg. Co. | EMA |
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