FDA Product Code
FDA Product Code EMA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3275
510(k) Clearances — 509 records · page 5 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K896883 | GC CERVICAL CEMENT | G-C Intl. Corp. | 1990-07-06 | Traditional | PDF ↗ |
| K902041 | 3M LUTING CEMENT - PASTE A AND PASTE B | 3M Company | 1990-06-27 | Traditional | PDF ↗ |
| K896340 | BIOMER(R) F COMPOSITE LUTING CEMENT | Dentsply Intl. | 1990-05-15 | Traditional | PDF ↗ |
| K900342 | UNITY DENTAL CEMENT | Whaledent Intl. Div. Ipco | 1990-05-07 | Traditional | PDF ↗ |
| K895386 | GLASION | Scientific Pharmaceuticals, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K900303 | CONNECT | Parkell | 1990-04-12 | Traditional | PDF ↗ |
| K895487 | TEMPORARY DENTAL CEMENT | Dentsply Intl. | 1990-04-02 | Traditional | PDF ↗ |
| K897188 | KETAC-CEM MAXICAP | Espe GmbH (Us) | 1990-03-27 | Traditional | PDF ↗ |
| K895988 | POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL | Milton Hodosh, M.D. | 1990-03-07 | Traditional | PDF ↗ |
| K896649 | GRANITEC Z2, ZINC PHOSPHATE CEMENT | Confi-Dental Products Co. | 1990-02-22 | Traditional | PDF ↗ |
| K894953 | GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS | Confi-Dental Products Co. | 1990-02-06 | Traditional | PDF ↗ |
| K896249 | BANDTITE GLASS IONOMER CEMENT | American Orthodontics | 1990-01-26 | Traditional | PDF ↗ |
| K894477 | INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM | Cosmedent, Inc. | 1990-01-10 | Traditional | PDF ↗ |
| K895798 | SILCOT COPAL CAVITY VARNISH | Specialites Septodont | 1989-12-21 | Traditional | PDF ↗ |
| K892453 | KULZER GLAS-IONOMER CEMENT | Kulzer, Inc. | 1989-12-04 | Traditional | PDF ↗ |
| K894219 | TEMP BOND NE | Kerr Corporation (Danbury) | 1989-09-18 | Traditional | PDF ↗ |
| K891607 | DENTANURSE | The Irish Scene | 1989-08-11 | Traditional | PDF ↗ |
| K884652 | OCTYLDENT | Crx Medical, Inc. | 1989-05-24 | Traditional | PDF ↗ |
| K890623 | FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT | Macrochem Corp. | 1989-04-17 | Traditional | PDF ↗ |
| K890608 | FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT | Macrochem Corp. | 1989-04-17 | Traditional | PDF ↗ |
| K885007 | CIMPAT S TEMPORARY DENTAL CEMENT | Specialites Septodont | 1989-03-01 | Traditional | PDF ↗ |
| K882417 | POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT | Milton Hodosh, M.D. | 1989-02-13 | Traditional | PDF ↗ |
| K884475 | CHELON-FIL | Espe GmbH (Us) | 1988-12-05 | Traditional | PDF ↗ |
| K884081 | INTERIM, TEMPORARY CEMENT | Scientific Pharmaceuticals, Inc. | 1988-12-02 | Traditional | PDF ↗ |
| K883770 | RESUBMITTED EMA DENTIN CEMENT | G-C Intl. Corp. | 1988-11-30 | Traditional | PDF ↗ |
| K883698 | ZINC OXIDE EUGENOL TEMPORARY CEMENT | E&D Dental Manufacturing Co. | 1988-11-29 | Traditional | PDF ↗ |
| K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET | Coe Laboratories, Inc. | 1988-10-31 | Traditional | PDF ↗ |
| K881914 | COVER UP | Parkell | 1988-07-15 | Traditional | PDF ↗ |
| K881890 | PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT | Specialites Septodont | 1988-07-15 | Traditional | PDF ↗ |
| K881918 | LIGHT-CURED ZIONOMER CEMENT | Den-Mat Corp. | 1988-07-15 | Traditional | PDF ↗ |
| K881661 | IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT | Specialites Septodont | 1988-06-07 | Traditional | PDF ↗ |
| K880251 | KERR XR IONOMER | Kerr Corporation (Danbury) | 1988-06-01 | Traditional | PDF ↗ |
| K880250 | KERR XR BOND | Kerr Corporation (Danbury) | 1988-06-01 | Traditional | PDF ↗ |
| K880848 | FUJI CAP II CAPSULE & APPLIER | G-C Intl. Corp. | 1988-05-16 | Traditional | PDF ↗ |
| K880685 | PORCELITE DUAL CURE CEMENT | Kerr Corporation (Danbury) | 1988-05-11 | Traditional | PDF ↗ |
| K874788 | KETAC-BOND APLICAP | Espe GmbH (Us) | 1988-04-12 | Traditional | PDF ↗ |
| K874458 | PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER | Lustgarten Multi-Tech International, Inc. | 1988-03-18 | Traditional | PDF ↗ |
| K872984 | KETAC-CONDITIONER | Espe GmbH (Us) | 1988-03-09 | Traditional | PDF ↗ |
| K874945 | CEMENT LINER | Dentsply Intl. | 1988-02-19 | Traditional | PDF ↗ |
| K874500 | GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. | Harry J. Bosworth Co. | 1988-02-18 | Traditional | PDF ↗ |
| K873356 | INSURE PORCELAIN VENEER BONDING SYSTEM | Cosmedent, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K871562 | IONOCAL | Foremost Dental Mfg., Inc. | 1987-05-20 | Traditional | PDF ↗ |
| K864720 | LIGHT-CURED PERIODONTAL DRESSING | Dentsply Intl. | 1987-04-07 | Traditional | PDF ↗ |
| K870211 | BONDEX* GLASS IONOMER CEMENT | Johnson & Johnson Professionals, Inc. | 1987-03-18 | Traditional | PDF ↗ |
| K870334 | BOSTON POST CEMENT | Scientific Pharmaceuticals, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K870209 | NEXADENT (DENTAL CEMENT) | Bionexus, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K864898 | FOREMOST DENTIN ADHESIVE | Foremost Dental Mfg., Inc. | 1987-02-12 | Traditional | PDF ↗ |
| K864725 | MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES | Dentsply Intl. | 1987-01-21 | Traditional | PDF ↗ |
| K864270 | 3M GLASS IONOMER LINER | 3M Company | 1986-12-16 | Traditional | PDF ↗ |
| K863141 | KULZER GLASS IONOMER LINER | Shofu Dental Corp. | 1986-08-26 | Traditional | PDF ↗ |
| K862280 | SHOFU LINING CEMENT | Shofu Dental Corp. | 1986-06-23 | Traditional | PDF ↗ |
| K861685 | SUPERLON (UNILON) CARBOXYLATE CEMENT | Carlisle Laboratories, Inc. | 1986-05-19 | Traditional | PDF ↗ |
| K861005 | GLASIONOMER BASE CEMENT | Shofu Dental Corp. | 1986-04-25 | Traditional | PDF ↗ |
| K855211 | PANAVIA EX, A DENTAL ADHESIVE | Kuraray Co. | 1986-03-13 | Traditional | PDF ↗ |
| K853090 | CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO | Psp Dental Co., Ltd. | 1986-01-21 | Traditional | PDF ↗ |
| K853091 | CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE | Psp Dental Co., Ltd. | 1986-01-21 | Traditional | PDF ↗ |
| K853447 | POLYCARB WATER SET | Pulpdent Corp. of America | 1985-10-16 | Traditional | PDF ↗ |
| K852196 | ZIONOMER CEMENT | Den-Mat Corp. | 1985-06-20 | Traditional | PDF ↗ |
| K851468 | 76 EMA LINING CEMENT | G-C Intl. Corp. | 1985-05-01 | Traditional | PDF ↗ |
| K850913 | GLAS IONOMER CEMENT | Shofu Dental Corp. | 1985-04-10 | Traditional | PDF ↗ |
| K844846 | ESPE KETAC-CEM RADIOPAQUE | Espe GmbH (Us) | 1985-03-25 | Traditional | PDF ↗ |
| K843566 | KETAC-SILVER | Espe GmbH (Us) | 1984-12-06 | Traditional | PDF ↗ |
| K842995 | EMA LIV CENERA DENTAL CEMENT | Int'L Corp. | 1984-10-30 | Traditional | PDF ↗ |
| K842994 | EMA FREEGENOL DENTAL CEMENT | Int'L Corp. | 1984-10-18 | Traditional | PDF ↗ |
| K840407 | KERR RESIN BONDED BRIDGE CEMENT | Sybron Corp. | 1984-05-21 | Traditional | PDF ↗ |
| K841195 | GLAS IONOMER CEMENT | Shofu Dental Corp. | 1984-05-14 | Traditional | PDF ↗ |
| K841196 | HY-BOND ZINC OXIDE EUGENOL TEMP. | Shofu Dental Corp. | 1984-05-11 | Traditional | PDF ↗ |
| K830113 | SEPTOPACK | North Pacific Dental, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830440 | DENTA PLAST | Denta, Inc. | 1983-04-28 | Traditional | PDF ↗ |
| K830117 | ENDOMET | North Pacific Dental, Inc. | 1983-03-01 | Traditional | PDF ↗ |
| K830107 | SELFAST | North Pacific Dental, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K823935 | MICRO JOIN, CROWN & BRIDGE ADHESIVE | Sci-Pharm, Inc. | 1983-02-07 | Traditional | PDF ↗ |
| K823795 | EVERBOND GLASS IONOMER CEMENT | Sybron Corp. | 1983-01-26 | Traditional | PDF ↗ |
| K821824 | TEM-STIK | Coralite Dental Products, Inc. | 1982-07-06 | Traditional | PDF ↗ |
| K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT | Cutter Laboratories, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT | Cutter Laboratories, Inc. | 1982-03-02 | Traditional | PDF ↗ |
| K813380 | CAVIDENTIN | Bitan Int'L Marketing Co. | 1982-02-24 | Traditional | PDF ↗ |
| K812858 | CHEMFIL | Dentsply Intl. | 1981-12-31 | Traditional | PDF ↗ |
| K812532 | TEMP-FILL | Madrid Uso, Jr., D.D.S. | 1981-10-14 | Traditional | PDF ↗ |
| K812568 | CAVITRON | G-C Intl. Corp. | 1981-09-25 | Traditional | PDF ↗ |
| K812115 | KETAC-CHEM | Espe-Premier Sales Co. | 1981-08-31 | Traditional | PDF ↗ |
| K811521 | FUJI IONOMER TYPE I & II | G-C Intl. Corp. | 1981-06-26 | Traditional | PDF ↗ |
| K810764 | HY-BOND POLYCARBOXYLATE CEMENT | Shofu Dental Corp. | 1981-06-12 | Traditional | PDF ↗ |
| K810765 | HY-BOND ZINC PHOSPHATE CEMENT | Shofu Dental Corp. | 1981-06-12 | Traditional | PDF ↗ |
| K810545 | PCA PERIOCARE PERIODONTAL DRESSING | Pulpdent Corp. of America | 1981-03-24 | Traditional | PDF ↗ |
| K810026 | DENTAL ENDODONTIC CEMENT | Witech Laboratory | 1981-01-28 | Traditional | PDF ↗ |
| K802662 | POLYCARBONATE TEMPORARY CEMENT | Buffalo Dental Mfg. Co., Inc. | 1980-12-16 | Traditional | PDF ↗ |
| K802819 | KETAC-CEM IN REF. TO K802048 | Espe Dental Products | 1980-11-24 | Traditional | PDF ↗ |
| K801227 | SILICAP | Vivadent (Usa), Inc. | 1980-08-12 | Traditional | PDF ↗ |
| K801236 | REIGNING EPOXY RESIN CEMENT | Oki Shiks USA , Ltd. | 1980-07-08 | Traditional | PDF ↗ |
| K801229 | BONDALCAP (CARBOXYLATE) | Vivadent (Usa), Inc. | 1980-06-04 | Traditional | PDF ↗ |
| K801228 | BONDALCAP (SILICO-PHOSPHATE) | Vivadent (Usa), Inc. | 1980-06-04 | Traditional | PDF ↗ |
| K791160 | DENTALEEN | Denpac Corp. | 1980-02-21 | Traditional | PDF ↗ |
| K800060 | PROVIT | Parker Laboratories, Inc. | 1980-01-23 | Traditional | PDF ↗ |
| K790593 | DENTAL CEMENT, ZINC PHOSPHATE | Wallace A. Erickson & Co. | 1979-06-15 | Traditional | PDF ↗ |
| K790586 | CHEMBOND | L.D. Caulk Co. | 1979-05-16 | Traditional | PDF ↗ |
| K790832 | KETAC APPLIC-CAPSULES | Espe GmbH (Us) | 1979-04-30 | Traditional | PDF ↗ |
| K790127 | CEMENT, CERAMCO | Johnson & Johnson Professionals, Inc. | 1979-02-26 | Traditional | PDF ↗ |
| K781281 | CEMENT, DENTAL/CAVITY LINER | Star Dental Mfg. Co. | 1978-08-21 | Traditional | PDF ↗ |
| K780301 | CAULK TYLOK | L.D. Caulk Co. | 1978-02-28 | Traditional | PDF ↗ |
Product code EMA · Class II · Dental. Data: openFDA.