FDA Product Code
FDA Product Code EBC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3765
510(k) Clearances — 131 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K870579 | ALPHA-DENT PIT AND FISSURE SEALANT | Wallace A. Erickson & Co. | 1987-03-02 | Traditional | PDF ↗ |
| K862695 | FLUOR-ETCH GEL ETCHANT | Teledyne, Inc. | 1986-07-31 | Traditional | PDF ↗ |
| K862660 | PRISMA METAL OPAQUERS | Dentsply Intl. | 1986-07-31 | Traditional | PDF ↗ |
| K862284 | SEALITE | Sybron Corp. | 1986-06-23 | Traditional | PDF ↗ |
| K861245 | ORTHOSOURCE ETCH SYSTEMS | Ortho Source | 1986-04-11 | Traditional | PDF ↗ |
| K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT | Lee Pharmaceuticals | 1986-01-30 | Traditional | PDF ↗ |
| K854494 | CERAM-ETCH | Gresco Products, Inc. | 1985-12-23 | Traditional | PDF ↗ |
| K845034 | FOREMOST LITE CURE PIT & FISSURE SEALANT | Foremost Dental Mfg., Inc. | 1985-03-18 | Traditional | PDF ↗ |
| K844308 | PIT AND FISSURE SEAANTS | Dentsply Intl. | 1985-01-09 | Traditional | PDF ↗ |
| K844211 | CONCISE LIGHT CURED WHITE SEALANT | 3M Company | 1985-01-07 | Traditional | PDF ↗ |
| K844057 | C-22 PIT & FISSURE SEALANT | Pentron Corp. | 1984-12-03 | Traditional | PDF ↗ |
| K843024 | COMMAND ULTRASEAL PIT & FISSURE SEALANT | Kerr Corporation (Danbury) | 1984-09-27 | Traditional | PDF ↗ |
| K843098 | APCO FISSURE SEALER & BONDING AGENT | Scientific Pharmaceuticals, Inc. | 1984-09-07 | Traditional | PDF ↗ |
| K842392 | DELTON * OPAQUE LIGHT CURING PIT | Johnson & Johnson Professionals, Inc. | 1984-07-26 | Traditional | PDF ↗ |
| K831380 | DELTON LIGHT CURING PIT & FISSURE | Johnson & Johnson Professionals, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K813015 | HELIOSEAL | Vivadent (Usa), Inc. | 1981-12-02 | Traditional | PDF ↗ |
| K813091 | FISSURE SEALER & BONDING AGENT | Sci-Pharm, Inc. | 1981-11-24 | Traditional | PDF ↗ |
| K812549 | BEAUSEAL | Sci-Pharm, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K811624 | VISIO-SEAL | Espe-Premier Sales Co. | 1981-06-26 | Traditional | PDF ↗ |
| K810950 | VISIO-SEAL | Espe Dental Products | 1981-04-29 | Traditional | PDF ↗ |
| K802682 | CONTACT SEAL | Vivadent (Usa), Inc. | 1980-11-24 | Traditional | PDF ↗ |
| K802562 | PRISMA SEAL | Dentsply Intl. | 1980-11-12 | Traditional | PDF ↗ |
| K801274 | S.S. WHITE-PENNWALT PRELUDE PIT SEALANT | Pennwalt Corp. | 1980-06-09 | Traditional | PDF ↗ |
| K800391 | PAINT-ON-RESTORATIVE W/FISSURE SEALER | American Dental Research | 1980-04-10 | Traditional | PDF ↗ |
| K790935 | DELTON* PIT AND FISSURE SEALENT | Johnson & Johnson Professionals, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K790788 | FISSURE SEALER AND BONDING AGENT | Scientific Pharmaceuticals, Inc. | 1979-07-06 | Traditional | PDF ↗ |
| K790596 | ENAMEL BOND SYSTEM | Wallace A. Erickson & Co. | 1979-06-15 | Traditional | PDF ↗ |
| K771402 | NUVA-COTE (MODIFICATION TO) | L.D. Caulk Co. | 1977-08-26 | Traditional | PDF ↗ |
| K771327 | UVIOFIL | Espe GmbH (Us) | 1977-08-02 | Traditional | PDF ↗ |
| K760405 | SEALANT, NEW FILLED | L.D. Caulk Co. | 1976-08-23 | Traditional | PDF ↗ |
| K760418 | 9075 | Lee Pharmaceuticals | 1976-08-23 | Traditional | PDF ↗ |
Product code EBC · Class II · Dental. Data: openFDA.