FDA Product Code
FDA Product Code EBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3690
510(k) Clearances — 937 records · page 9 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K862449 | DEN-MAT DENTIN LINK | Den-Mat Corp. | 1986-07-22 | Traditional | PDF ↗ |
| K862648 | V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT | Scientific Pharmaceuticals, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K861833 | RESTOR (COMET)*DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | 1986-07-09 | Traditional | PDF ↗ |
| K861899 | SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE | 3M Company | 1986-06-25 | Traditional | PDF ↗ |
| K860487 | URENAMEL, POSTERIOR RESTORATIVE MATERIAL | Cadco Dental Products, Inc. | 1986-05-30 | Traditional | PDF ↗ |
| K861546 | REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT | Macrochem Corp. | 1986-05-21 | Traditional | PDF ↗ |
| K861740 | P-50 LIGHT CURED RESIN BONDED CERAMIC | 3M Company | 1986-05-21 | Traditional | PDF ↗ |
| K861148 | BISCO'S PORCELAIN VENEER SYSTEM | Bisco, Inc. | 1986-04-30 | Traditional | PDF ↗ |
| K860708 | PHOTO CLEARFIL OPAQUER | Kuraray Co. | 1986-04-17 | Traditional | PDF ↗ |
| K860626 | NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID | Scientific Pharmaceuticals, Inc. | 1986-04-08 | Traditional | PDF ↗ |
| K860627 | SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE | Scientific Pharmaceuticals, Inc. | 1986-03-26 | Traditional | PDF ↗ |
| K854755 | RENAMEL ESTHETIC RESTORATIVE SYSTEM | Cosmedent, Inc. | 1986-03-13 | Traditional | PDF ↗ |
| K854803 | CHAMELEON BONDING KIT | Pentron Corp. | 1986-03-04 | Traditional | PDF ↗ |
| K853055 | LIGHT CURE FILLING MATERIAL | Foremost Dental Mfg., Inc. | 1985-11-19 | Traditional | PDF ↗ |
| K853431 | DENTAL CEMENT | Dentsply Intl. | 1985-10-31 | Traditional | PDF ↗ |
| K852868 | WUNDERSHADE | Harry J. Bosworth Co. | 1985-09-27 | Traditional | PDF ↗ |
| K852744 | CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR | The S. S. White Co. | 1985-08-16 | Traditional | PDF ↗ |
| K852745 | PORCELAIN VENEER SYSTEM BONDING KIT | The S. S. White Co. | 1985-08-16 | Traditional | PDF ↗ |
| K853001 | BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) | Bisco, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K853002 | BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR) | Bisco, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K851929 | RESTORE* | Johnson & Johnson Professionals, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K852659 | BIOGLOSS | Dentsply Intl. | 1985-07-30 | Traditional | PDF ↗ |
| K852658 | ETEN-GEL | Dentsply Intl. | 1985-07-24 | Traditional | PDF ↗ |
| K852151 | PHOTO CURING LIGHT | Dentsply Intl. | 1985-07-01 | Traditional | PDF ↗ |
| K852344 | DISTALITE POSTERIA DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | 1985-07-01 | Traditional | PDF ↗ |
| K851459 | VISILUX 2 VISIBLE LIGHT CURING UNIT | 3M Company | 1985-05-21 | Traditional | PDF ↗ |
| K850965 | KULZER DENTIN ADHESIVE | Kulzer, Inc. | 1985-04-22 | Traditional | PDF ↗ |
| K850911 | TRIAD C & B MATERIAL | Dentsply Intl. | 1985-04-16 | Traditional | PDF ↗ |
| K850824 | PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST | Kuraray Co. | 1985-04-08 | Traditional | PDF ↗ |
| K844662 | KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI | Kerr Corporation (Danbury) | 1985-03-25 | Traditional | PDF ↗ |
| K845033 | FOREMOST DENTIN ADHESIVE | Foremost Dental Mfg., Inc. | 1985-03-18 | Traditional | PDF ↗ |
| K844326 | OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE | Coe Laboratories, Inc. | 1984-12-03 | Traditional | PDF ↗ |
| K843363 | RESTODENT VL | Lee Pharmaceuticals | 1984-10-25 | Traditional | PDF ↗ |
| K843026 | KERR GELLED PHOSPHORIC ACID ETCHANT | Kerr Corporation (Danbury) | 1984-09-27 | Traditional | PDF ↗ |
| K843072 | EVER-BOND V GLASS LONOMER RESTORATIVE | Kerr Corporation (Danbury) | 1984-09-07 | Traditional | PDF ↗ |
| K842087 | BISFIL-I LIGHT CURABLE POSTERIOR COMPO | Bisco, Inc. | 1984-07-12 | Traditional | PDF ↗ |
| K841550 | SCOTCHBOND LIGHT CURED DENTAL ADHES | 3M Company | 1984-06-22 | Traditional | PDF ↗ |
| K841667 | WUNDERFIL | Harry J. Bosworth Co. | 1984-05-22 | Traditional | PDF ↗ |
| K841268 | C-17 | Pentron Corp. | 1984-05-22 | Traditional | PDF ↗ |
| K841269 | C-19 | Pentron Corp. | 1984-05-22 | Traditional | PDF ↗ |
| K841518 | JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II) | Johnson & Johnson Professionals, Inc. | 1984-05-21 | Traditional | PDF ↗ |
| K841267 | C-18 | Pentron Corp. | 1984-04-30 | Traditional | PDF ↗ |
| K833797 | LIGHT CURED RESIN BONDED CERAMIC | 3M Company | 1984-04-25 | Traditional | PDF ↗ |
| K840727 | PENTRA-FIL II | Pentron Corp. | 1984-04-13 | Traditional | PDF ↗ |
| K840176 | ESTIC MICROFILL | Kulzer, Inc. | 1984-04-13 | Traditional | PDF ↗ |
| K841111 | REMBRANDT SHADE MODIFICATION KIT | Den-Mat Corp. | 1984-03-30 | Traditional | PDF ↗ |
| K840084 | COLTENE BRILLIANT LUX | Bauer, Cheng & Associates, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K833725 | PRE-LOADED C-R TUBES FOR SYRINGE | Centrix, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840085 | COLTENE BRILLIANT | Bauer, Cheng & Associates, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K833810 | CURAY-MATCH PAINT-ON COMPOSITE RESTOR | Scientific Pharmaceuticals, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K834247 | MATERIAL TOOTHSADE RESIN | Scientific Pharmaceuticals, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K833757 | VISIO-GEM | Espe GmbH (Us) | 1984-02-03 | Traditional | PDF ↗ |
| K834046 | LUXENE VINYL-JECT 3600-80 | Howmedica Corp. | 1984-02-03 | Traditional | PDF ↗ |
| K831351 | PERMALUX VISIBLE CURE COMPOSITE RESTOR | Lares Manufacturing Co., Inc. | 1983-11-14 | Traditional | PDF ↗ |
| K832781 | CURAY-SUPPORT, CORE BUILD-UP MATERIAL | Scientific Pharmaceuticals, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K831215 | DENTACOLOR LIGHT CURING CROWN & BRIDGE | Kulzer, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K832062 | ADAPTIC*FAST SET DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K832061 | LIGHT CURING BONDING AGENT | Johnson & Johnson Professionals, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K831484 | COMPOSI-GLAZE | Denpac Corp. | 1983-07-28 | Traditional | PDF ↗ |
| K831559 | CERTAIN *DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K830513 | FIRST TM | Phasealloy | 1983-05-09 | Traditional | PDF ↗ |
| K830442 | PRISMA-FINE | Dentsply Intl. | 1983-03-17 | Traditional | PDF ↗ |
| K830380 | MICRODAPT DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K823510 | CURAY ANTERIOR/POSTERIOR RESTORATIVE | Scientific Pharmaceuticals, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823185 | GAMMA LIGHT CURING DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K822450 | AURAFILL* DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K822453 | VISIO-OPAQUER | Espe GmbH (Us) | 1982-09-14 | Traditional | PDF ↗ |
| K821895 | AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR | American Midwest | 1982-07-16 | Traditional | PDF ↗ |
| K820028 | ZEON COMPOSITE RESIN LIGHT CURE SYS | National Patent Development Corp. | 1982-03-11 | Traditional | PDF ↗ |
| K820182 | SYBRON/KERR COMMAND | Sybron Corp. | 1982-03-02 | Traditional | PDF ↗ |
| K813568 | ESTILUX POSTERIOR XR | Kulzer, Inc. | 1982-01-29 | Traditional | PDF ↗ |
| K820006 | ZEON COMPOSITE RESIN SYSTEM | National Patent Development Corp. | 1982-01-22 | Traditional | PDF ↗ |
| K813357 | CAULK OPAQUER | Dentsply Intl. | 1982-01-07 | Traditional | PDF ↗ |
| K813090 | COMPOSITE DENTAL RESTORATIVE MATERIAL | Sci-Pharm, Inc. | 1981-11-24 | Traditional | PDF ↗ |
| K812889 | ESTILUX POSTERIOR | Kulzer, Inc. | 1981-11-17 | Traditional | PDF ↗ |
| K812449 | ADAPTIC* C.F.S. | Johnson & Johnson Professionals, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K812545 | BEAUFILL | Sci-Pharm, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K812546 | BEAUDENT | Sci-Pharm, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K812551 | BEAUCOR | Sci-Pharm, Inc. | 1981-09-23 | Traditional | PDF ↗ |
| K812169 | VISIO-FIL | Espe GmbH (Us) | 1981-09-08 | Traditional | PDF ↗ |
| K812119 | NIMETIC-DISPERS | Espe-Premier Sales Co. | 1981-08-31 | Traditional | PDF ↗ |
| K811427 | SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM | Harry J. Bosworth Co. | 1981-08-20 | Traditional | PDF ↗ |
| K811979 | ATT-1 DENTAL COMPOSITE RESTORATIVE SYS | American Midwest | 1981-08-18 | Traditional | PDF ↗ |
| K811669 | DURAFILL MICROFILL RESTORATIVE MATERIAL | Kulzer, Inc. | 1981-07-01 | Traditional | PDF ↗ |
| K811363 | COLTENE DRS DENTAL RESTORATIVE SYSTEM | Coltene, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K811443 | ENHANCE DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K810969 | ISOSIT C & B MATERIAL | Bauer, Cheng & Associates, Inc. | 1981-05-05 | Traditional | PDF ↗ |
| K810595 | SILUX RESTORATIVE MATERIAL & ENAMEL BOND | 3M Company | 1981-03-24 | Traditional | PDF ↗ |
| K810479 | SUPPORT | Sci-Pharm, Inc. | 1981-03-17 | Traditional | PDF ↗ |
| K802975 | ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | Dentsply Intl. | 1981-01-14 | Traditional | PDF ↗ |
| K803227 | VISIO-DISPERS | Espe-Premier Sales Co. | 1981-01-14 | Traditional | PDF ↗ |
| K802535 | HYDROXYLATE DENTAL COMPOSITE RESTROATIVE | Wallace A. Erickson & Co. | 1980-12-18 | Traditional | PDF ↗ |
| K802683 | HELIOSIT | Vivadent (Usa), Inc. | 1980-11-24 | Traditional | PDF ↗ |
| K802680 | ISOPAST-DS | Vivadent (Usa), Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802125 | ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | Dentsply Intl. | 1980-09-16 | Traditional | PDF ↗ |
| K802049 | NIMETIC-DISPERS | Espe Dental Products | 1980-09-16 | Traditional | PDF ↗ |
| K801798 | COMPOSITE RESTORATIVE, PASTE/PASTE TYPE | Scientific Pharmaceuticals, Inc. | 1980-08-07 | Traditional | PDF ↗ |
| K801797 | SCI-PHARM PAINT-ON RESTORATIVE | Scientific Pharmaceuticals, Inc. | 1980-08-07 | Traditional | PDF ↗ |
| K801732 | PRISMA-FIL | Dentsply Intl. | 1980-08-07 | Traditional | PDF ↗ |
| K801529 | KERR CORE COMPOSITE | Sybron Corp. | 1980-08-04 | Traditional | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.