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 |
|---|---|---|---|
| Jul 6, 1990 | K896883 | GC CERVICAL CEMENT G-C Intl. Corp. | EMA |
| Jun 27, 1990 | K902041 | 3M LUTING CEMENT - PASTE A AND PASTE B 3M Company | EMA |
| May 15, 1990 | K896340 | BIOMER(R) F COMPOSITE LUTING CEMENT Dentsply Intl. | EMA |
| May 7, 1990 | K900342 | UNITY DENTAL CEMENT Whaledent Intl. Div. Ipco | EMA |
| Apr 16, 1990 | K895386 | GLASION Scientific Pharmaceuticals, Inc. | EMA |
| Apr 12, 1990 | K900303 | CONNECT Parkell | EMA |
| Apr 2, 1990 | K895487 | TEMPORARY DENTAL CEMENT Dentsply Intl. | EMA |
| Mar 27, 1990 | K897188 | KETAC-CEM MAXICAP Espe GmbH (Us) | EMA |
| Mar 7, 1990 | K895988 | POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL Milton Hodosh, M.D. | EMA |
| Feb 22, 1990 | K896649 | GRANITEC Z2, ZINC PHOSPHATE CEMENT Confi-Dental Products Co. | EMA |
| Feb 6, 1990 | K894953 | GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS Confi-Dental Products Co. | EMA |
| Jan 26, 1990 | K896249 | BANDTITE GLASS IONOMER CEMENT American Orthodontics | EMA |
| Jan 10, 1990 | K894477 | INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM Cosmedent, Inc. | EMA |
| Dec 21, 1989 | K895798 | SILCOT COPAL CAVITY VARNISH Specialites Septodont | EMA |
| Dec 4, 1989 | K892453 | KULZER GLAS-IONOMER CEMENT Kulzer, Inc. | EMA |
| Sep 18, 1989 | K894219 | TEMP BOND NE Kerr Corporation (Danbury) | EMA |
| Aug 11, 1989 | K891607 | DENTANURSE The Irish Scene | EMA |
| May 24, 1989 | K884652 | OCTYLDENT Crx Medical, Inc. | EMA |
| Apr 17, 1989 | K890623 | FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT Macrochem Corp. | EMA |
| Apr 17, 1989 | K890608 | FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT Macrochem Corp. | EMA |
| Mar 1, 1989 | K885007 | CIMPAT S TEMPORARY DENTAL CEMENT Specialites Septodont | EMA |
| Feb 13, 1989 | K882417 | POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT Milton Hodosh, M.D. | EMA |
| Dec 5, 1988 | K884475 | CHELON-FIL Espe GmbH (Us) | EMA |
| Dec 2, 1988 | K884081 | INTERIM, TEMPORARY CEMENT Scientific Pharmaceuticals, Inc. | EMA |
| Nov 30, 1988 | K883770 | RESUBMITTED EMA DENTIN CEMENT G-C Intl. Corp. | EMA |
| Nov 29, 1988 | K883698 | ZINC OXIDE EUGENOL TEMPORARY CEMENT E&D Dental Manufacturing Co. | EMA |
| Oct 31, 1988 | K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET Coe Laboratories, Inc. | EMA |
| Jul 15, 1988 | K881918 | LIGHT-CURED ZIONOMER CEMENT Den-Mat Corp. | EMA |
| Jul 15, 1988 | K881914 | COVER UP Parkell | EMA |
| Jul 15, 1988 | K881890 | PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT Specialites Septodont | EMA |
| Jun 7, 1988 | K881661 | IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT Specialites Septodont | EMA |
| Jun 1, 1988 | K880251 | KERR XR IONOMER Kerr Corporation (Danbury) | EMA |
| Jun 1, 1988 | K880250 | KERR XR BOND Kerr Corporation (Danbury) | EMA |
| May 16, 1988 | K880848 | FUJI CAP II CAPSULE & APPLIER G-C Intl. Corp. | EMA |
| May 11, 1988 | K880685 | PORCELITE DUAL CURE CEMENT Kerr Corporation (Danbury) | EMA |
| Apr 12, 1988 | K874788 | KETAC-BOND APLICAP Espe GmbH (Us) | EMA |
| Mar 18, 1988 | K874458 | PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER Lustgarten Multi-Tech International, Inc. | EMA |
| Mar 9, 1988 | K872984 | KETAC-CONDITIONER Espe GmbH (Us) | EMA |
| Feb 19, 1988 | K874945 | CEMENT LINER Dentsply Intl. | EMA |
| Feb 18, 1988 | K874500 | GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. Harry J. Bosworth Co. | EMA |
| Dec 29, 1987 | K873356 | INSURE PORCELAIN VENEER BONDING SYSTEM Cosmedent, Inc. | EMA |
| May 20, 1987 | K871562 | IONOCAL Foremost Dental Mfg., Inc. | EMA |
| Apr 7, 1987 | K864720 | LIGHT-CURED PERIODONTAL DRESSING Dentsply Intl. | EMA |
| Mar 18, 1987 | K870211 | BONDEX* GLASS IONOMER CEMENT Johnson & Johnson Professionals, Inc. | EMA |
| Feb 19, 1987 | K870334 | BOSTON POST CEMENT Scientific Pharmaceuticals, Inc. | EMA |
| Feb 19, 1987 | K870209 | NEXADENT (DENTAL CEMENT) Bionexus, Inc. | EMA |
| Feb 12, 1987 | K864898 | FOREMOST DENTIN ADHESIVE Foremost Dental Mfg., Inc. | EMA |
| Jan 21, 1987 | K864725 | MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES Dentsply Intl. | EMA |
| Dec 16, 1986 | K864270 | 3M GLASS IONOMER LINER 3M Company | EMA |
| Aug 26, 1986 | K863141 | KULZER GLASS IONOMER LINER Shofu Dental Corp. | EMA |
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