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 |
|---|---|---|---|
| Sep 10, 1996 | K963078 | STERI-OSS TEMPORARY IMPLANT CEMENT Steri-Oss, Inc. | EMA |
| Sep 3, 1996 | K962383 | PULPDENT RESILUTE II Pulpdent Corp. | EMA |
| Jul 18, 1996 | K962065 | 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE 3M Company | EMA |
| Jul 8, 1996 | K961448 | FUJI IX GP GC America, Inc. | EMA |
| Jun 26, 1996 | K962297 | VIVAGLASS CEM Ivoclar North America, Inc. | EMA |
| Jun 26, 1996 | K961910 | VIVAGLASS FIL Ivoclar North America, Inc. | EMA |
| May 24, 1996 | K961584 | FUJI II LC (IMPROVED) GC America, Inc. | EMA |
| May 16, 1996 | K960954 | KETAC-MOLAR APLICAP Espe GmbH & Co. Kg., DE | EMA |
| Mar 28, 1996 | K960910 | INDERMIL DENTAL Loctite Corp. | EMA |
| Feb 26, 1996 | K960464 | C & B METABOND (MODIFICATION) Parkell, Inc. | EMA |
| Dec 13, 1995 | K955089 | ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT Wallace A. Erickson & Co. | EMA |
| Dec 11, 1995 | K955068 | OPTIBOND 2A PRECOAT Sybron Dental Specialties, Inc. | EMA |
| Dec 1, 1995 | K955017 | PULPDENT RESILUTE Pulpdent Corp. | EMA |
| Nov 15, 1995 | K954876 | AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA American Dental Products, Inc. | EMA |
| Nov 2, 1995 | K954762 | NEXUS Sybron Dental Specialties, Inc. | EMA |
| Oct 19, 1995 | K954643 | TRY-IN GEL Sybron Dental Specialties, Inc. | EMA |
| Sep 27, 1995 | K954177 | ALPHA-BOND DENTIN BONDING SYSTEM Alpha-Bond, Inc. | EMA |
| Aug 25, 1995 | K953301 | DENTASTIC ONE-STEP Pulpdent Corp. | EMA |
| Aug 25, 1995 | K953272 | PULPDENT DENTASTIC II Pulpdent Corp. | EMA |
| Jul 19, 1995 | K952960 | PULPDENT POST CEMENT Pulpdent Corp. | EMA |
| Jun 22, 1995 | K952121 | 3M RESIN CEMENT 3M Medical Products Group | EMA |
| May 31, 1995 | K951270 | PULPDENT GLASS IONOMER CEMENTS Pulpdent Corp. | EMA |
| May 23, 1995 | K951555 | FUJI IX GC America, Inc. | EMA |
| Feb 27, 1995 | K945451 | HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE Shofu Dental Corp. | EMA |
| Feb 17, 1995 | K950428 | VIVAGLASS BASE Ivoclar North America, Inc. | EMA |
| Feb 10, 1995 | K950060 | PROVILINK Ivoclar North America, Inc. | EMA |
| Feb 2, 1995 | K945366 | PARAPOST CEMENT Coltene/Whaledent, Inc. | EMA |
| Jan 26, 1995 | K946137 | PULPDENT PERIODONTAL DRESSINGS Pulpdent Corp. | EMA |
| Jan 20, 1995 | K946100 | FUJI DUET GC America, Inc. | EMA |
| Dec 29, 1994 | K945244 | PULP CANAL SEALER EWT Sybron Dental Specialties, Inc. | EMA |
| Nov 3, 1994 | K944480 | SEALAPEX Sybron Dental Specialties, Inc. | EMA |
| Nov 3, 1994 | K942808 | TYPE I GLASS IONOMER CEMENT Mion International Corp. | EMA |
| Oct 21, 1994 | K926376 | MION 525 Mion International Corp. | EMA |
| Aug 29, 1994 | K940914 | NEW LUTING CEMENT MATERIAL (NLC) Dentsply Intl. | EMA |
| Jul 22, 1994 | K942665 | ORTHOCENT: LIQUID AND POWDER Dentauraum, Inc. | EMA |
| Jun 16, 1994 | K942596 | ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT Wallace A. Erickson & Co. | EMA |
| Jun 16, 1994 | K941065 | DEOX, OXYGEN BARRIER VISCOUS SOLUTION Ultradent Products, Inc. | EMA |
| Jun 10, 1994 | K935436 | ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED Wallace A. Erickson & Co. | EMA |
| May 2, 1994 | K940122 | HY BOND, GLASIONOMER CX Shofu Dental Corp. | EMA |
| Apr 29, 1994 | K940546 | GRANITEC IONOMER RESIN CEMENT Confi-Dental Products Co. | EMA |
| Apr 29, 1994 | K940459 | MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) Dentsply Intl. | EMA |
| Feb 24, 1994 | K933612 | JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) Jedental Co., Inc. | EMA |
| Feb 24, 1994 | K933030 | PANAVIA 21 Kuraray Co. | EMA |
| Feb 4, 1994 | K940030 | BISCO COMPOSITE Bisco, Inc. | EMA |
| Jan 26, 1994 | K934073 | JEDENTAL GLASS IONOMER CEMENT AND LINER Jedental Co., Inc. | EMA |
| Jan 26, 1994 | K922250 | FLEXI-FLOW CEMENT WITH TITANIUM Essential Dental Systems, Inc. | EMA |
| Jan 26, 1994 | K922249 | FLEXI-FLOW CEMENT NATURAL Essential Dental Systems, Inc. | EMA |
| Jan 21, 1994 | K934405 | PRECEDENT Reliance Orthodontic Products, Inc. | EMA |
| Jan 6, 1994 | K935521 | GC ELITE CEMENT GC America, Inc. | EMA |
| Jan 6, 1994 | K933199 | CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL Confi-Dental Products Co. | EMA |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.