Sealant, Pit And Fissure, And Conditioner
Regulation 872.3765
1510(k)s in 12 months (131 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in EBC
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 11 | 0 |
| Pulpdent Corp. | 10 | 0 |
| Ultradent Products, Inc. | 7 | 1 |
| Voco GmbH | 5 | 0 |
| Confi-Dental Products Co. | 4 | 0 |
| 3M Company | 3 | 0 |
| Bisco, Inc. | 3 | 0 |
| Foremost Dental Mfg., Inc. | 3 | 0 |
| Harry J. Bosworth Co. | 3 | 0 |
| Johnson & Johnson Professionals, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 1987 | K870579 | ALPHA-DENT PIT AND FISSURE SEALANT Wallace A. Erickson & Co. | EBC |
| Jul 31, 1986 | K862695 | FLUOR-ETCH GEL ETCHANT Teledyne, Inc. | EBC |
| Jul 31, 1986 | K862660 | PRISMA METAL OPAQUERS Dentsply Intl. | EBC |
| Jun 23, 1986 | K862284 | SEALITE Sybron Corp. | EBC |
| Apr 11, 1986 | K861245 | ORTHOSOURCE ETCH SYSTEMS Ortho Source | EBC |
| Jan 30, 1986 | K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT Lee Pharmaceuticals | EBC |
| Dec 23, 1985 | K854494 | CERAM-ETCH Gresco Products, Inc. | EBC |
| Mar 18, 1985 | K845034 | FOREMOST LITE CURE PIT & FISSURE SEALANT Foremost Dental Mfg., Inc. | EBC |
| Jan 9, 1985 | K844308 | PIT AND FISSURE SEAANTS Dentsply Intl. | EBC |
| Jan 7, 1985 | K844211 | CONCISE LIGHT CURED WHITE SEALANT 3M Company | EBC |
| Dec 3, 1984 | K844057 | C-22 PIT & FISSURE SEALANT Pentron Corp. | EBC |
| Sep 27, 1984 | K843024 | COMMAND ULTRASEAL PIT & FISSURE SEALANT Kerr Corporation (Danbury) | EBC |
| Sep 7, 1984 | K843098 | APCO FISSURE SEALER & BONDING AGENT Scientific Pharmaceuticals, Inc. | EBC |
| Jul 26, 1984 | K842392 | DELTON * OPAQUE LIGHT CURING PIT Johnson & Johnson Professionals, Inc. | EBC |
| Jun 30, 1983 | K831380 | DELTON LIGHT CURING PIT & FISSURE Johnson & Johnson Professionals, Inc. | EBC |
| Dec 2, 1981 | K813015 | HELIOSEAL Vivadent (Usa), Inc. | EBC |
| Nov 24, 1981 | K813091 | FISSURE SEALER & BONDING AGENT Sci-Pharm, Inc. | EBC |
| Sep 25, 1981 | K812549 | BEAUSEAL Sci-Pharm, Inc. | EBC |
| Jun 26, 1981 | K811624 | VISIO-SEAL Espe-Premier Sales Co. | EBC |
| Apr 29, 1981 | K810950 | VISIO-SEAL Espe Dental Products | EBC |
| Nov 24, 1980 | K802682 | CONTACT SEAL Vivadent (Usa), Inc. | EBC |
| Nov 12, 1980 | K802562 | PRISMA SEAL Dentsply Intl. | EBC |
| Jun 9, 1980 | K801274 | S.S. WHITE-PENNWALT PRELUDE PIT SEALANT Pennwalt Corp. | EBC |
| Apr 10, 1980 | K800391 | PAINT-ON-RESTORATIVE W/FISSURE SEALER American Dental Research | EBC |
| Aug 3, 1979 | K790935 | DELTON* PIT AND FISSURE SEALENT Johnson & Johnson Professionals, Inc. | EBC |
| Jul 6, 1979 | K790788 | FISSURE SEALER AND BONDING AGENT Scientific Pharmaceuticals, Inc. | EBC |
| Jun 15, 1979 | K790596 | ENAMEL BOND SYSTEM Wallace A. Erickson & Co. | EBC |
| Aug 26, 1977 | K771402 | NUVA-COTE (MODIFICATION TO) L.D. Caulk Co. | EBC |
| Aug 2, 1977 | K771327 | UVIOFIL Espe GmbH (Us) | EBC |
| Aug 23, 1976 | K760418 | 9075 Lee Pharmaceuticals | EBC |
| Aug 23, 1976 | K760405 | SEALANT, NEW FILLED L.D. Caulk Co. | EBC |
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