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 |
|---|---|---|---|
| Jun 23, 1986 | K862280 | SHOFU LINING CEMENT Shofu Dental Corp. | EMA |
| May 19, 1986 | K861685 | SUPERLON (UNILON) CARBOXYLATE CEMENT Carlisle Laboratories, Inc. | EMA |
| Apr 25, 1986 | K861005 | GLASIONOMER BASE CEMENT Shofu Dental Corp. | EMA |
| Mar 13, 1986 | K855211 | PANAVIA EX, A DENTAL ADHESIVE Kuraray Co. | EMA |
| Jan 21, 1986 | K853091 | CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE Psp Dental Co., Ltd., GB | EMA |
| Jan 21, 1986 | K853090 | CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO Psp Dental Co., Ltd., GB | EMA |
| Oct 16, 1985 | K853447 | POLYCARB WATER SET Pulpdent Corp. of America | EMA |
| Jun 20, 1985 | K852196 | ZIONOMER CEMENT Den-Mat Corp. | EMA |
| May 1, 1985 | K851468 | 76 EMA LINING CEMENT G-C Intl. Corp. | EMA |
| Apr 10, 1985 | K850913 | GLAS IONOMER CEMENT Shofu Dental Corp. | EMA |
| Mar 25, 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE Espe GmbH (Us) | EMA |
| Dec 6, 1984 | K843566 | KETAC-SILVER Espe GmbH (Us) | EMA |
| Oct 30, 1984 | K842995 | EMA LIV CENERA DENTAL CEMENT Int'L Corp. | EMA |
| Oct 18, 1984 | K842994 | EMA FREEGENOL DENTAL CEMENT Int'L Corp. | EMA |
| May 21, 1984 | K840407 | KERR RESIN BONDED BRIDGE CEMENT Sybron Corp. | EMA |
| May 14, 1984 | K841195 | GLAS IONOMER CEMENT Shofu Dental Corp. | EMA |
| May 11, 1984 | K841196 | HY-BOND ZINC OXIDE EUGENOL TEMP. Shofu Dental Corp. | EMA |
| May 9, 1983 | K830113 | SEPTOPACK North Pacific Dental, Inc. | EMA |
| Apr 28, 1983 | K830440 | DENTA PLAST Denta, Inc. | EMA |
| Mar 1, 1983 | K830117 | ENDOMET North Pacific Dental, Inc. | EMA |
| Feb 18, 1983 | K830107 | SELFAST North Pacific Dental, Inc. | EMA |
| Feb 7, 1983 | K823935 | MICRO JOIN, CROWN & BRIDGE ADHESIVE Sci-Pharm, Inc. | EMA |
| Jan 26, 1983 | K823795 | EVERBOND GLASS IONOMER CEMENT Sybron Corp. | EMA |
| Jul 6, 1982 | K821824 | TEM-STIK Coralite Dental Products, Inc. | EMA |
| May 28, 1982 | K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT Cutter Laboratories, Inc. | EMA |
| Mar 2, 1982 | K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT Cutter Laboratories, Inc. | EMA |
| Feb 24, 1982 | K813380 | CAVIDENTIN Bitan Int'L Marketing Co. | EMA |
| Dec 31, 1981 | K812858 | CHEMFIL Dentsply Intl. | EMA |
| Oct 14, 1981 | K812532 | TEMP-FILL Madrid Uso, Jr., D.D.S. | EMA |
| Sep 25, 1981 | K812568 | CAVITRON G-C Intl. Corp. | EMA |
| Aug 31, 1981 | K812115 | KETAC-CHEM Espe-Premier Sales Co. | EMA |
| Jun 26, 1981 | K811521 | FUJI IONOMER TYPE I & II G-C Intl. Corp. | EMA |
| Jun 12, 1981 | K810765 | HY-BOND ZINC PHOSPHATE CEMENT Shofu Dental Corp. | EMA |
| Jun 12, 1981 | K810764 | HY-BOND POLYCARBOXYLATE CEMENT Shofu Dental Corp. | EMA |
| Mar 24, 1981 | K810545 | PCA PERIOCARE PERIODONTAL DRESSING Pulpdent Corp. of America | EMA |
| Jan 28, 1981 | K810026 | DENTAL ENDODONTIC CEMENT Witech Laboratory | EMA |
| Dec 16, 1980 | K802662 | POLYCARBONATE TEMPORARY CEMENT Buffalo Dental Mfg. Co., Inc. | EMA |
| Nov 24, 1980 | K802819 | KETAC-CEM IN REF. TO K802048 Espe Dental Products | EMA |
| Aug 12, 1980 | K801227 | SILICAP Vivadent (Usa), Inc. | EMA |
| Jul 8, 1980 | K801236 | REIGNING EPOXY RESIN CEMENT Oki Shiks USA , Ltd. | EMA |
| Jun 4, 1980 | K801229 | BONDALCAP (CARBOXYLATE) Vivadent (Usa), Inc. | EMA |
| Jun 4, 1980 | K801228 | BONDALCAP (SILICO-PHOSPHATE) Vivadent (Usa), Inc. | EMA |
| Feb 21, 1980 | K791160 | DENTALEEN Denpac Corp. | EMA |
| Jan 23, 1980 | K800060 | PROVIT Parker Laboratories, Inc. | EMA |
| Jun 15, 1979 | K790593 | DENTAL CEMENT, ZINC PHOSPHATE Wallace A. Erickson & Co. | EMA |
| May 16, 1979 | K790586 | CHEMBOND L.D. Caulk Co. | EMA |
| Apr 30, 1979 | K790832 | KETAC APPLIC-CAPSULES Espe GmbH (Us) | EMA |
| Feb 26, 1979 | K790127 | CEMENT, CERAMCO Johnson & Johnson Professionals, Inc. | EMA |
| Aug 21, 1978 | K781281 | CEMENT, DENTAL/CAVITY LINER Star Dental Mfg. Co. | EMA |
| Feb 28, 1978 | K780301 | CAULK TYLOK L.D. Caulk Co. | EMA |
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