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 4 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K963078 | STERI-OSS TEMPORARY IMPLANT CEMENT | Steri-Oss, Inc. | 1996-09-10 | Traditional | PDF ↗ |
| K962383 | PULPDENT RESILUTE II | Pulpdent Corp. | 1996-09-03 | Traditional | PDF ↗ |
| K962065 | 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE | 3M Company | 1996-07-18 | Traditional | PDF ↗ |
| K961448 | FUJI IX GP | GC America, Inc. | 1996-07-08 | Traditional | PDF ↗ |
| K961910 | VIVAGLASS FIL | Ivoclar North America, Inc. | 1996-06-26 | Traditional | PDF ↗ |
| K962297 | VIVAGLASS CEM | Ivoclar North America, Inc. | 1996-06-26 | Traditional | PDF ↗ |
| K961584 | FUJI II LC (IMPROVED) | GC America, Inc. | 1996-05-24 | Traditional | PDF ↗ |
| K960954 | KETAC-MOLAR APLICAP | Espe GmbH & Co. Kg. | 1996-05-16 | Traditional | PDF ↗ |
| K960910 | INDERMIL DENTAL | Loctite Corp. | 1996-03-28 | Traditional | PDF ↗ |
| K960464 | C & B METABOND (MODIFICATION) | Parkell, Inc. | 1996-02-26 | Traditional | PDF ↗ |
| K955089 | ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT | Wallace A. Erickson & Co. | 1995-12-13 | Traditional | PDF ↗ |
| K955068 | OPTIBOND 2A PRECOAT | Sybron Dental Specialties, Inc. | 1995-12-11 | Traditional | PDF ↗ |
| K955017 | PULPDENT RESILUTE | Pulpdent Corp. | 1995-12-01 | Traditional | PDF ↗ |
| K954876 | AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA | American Dental Products, Inc. | 1995-11-15 | Traditional | PDF ↗ |
| K954762 | NEXUS | Sybron Dental Specialties, Inc. | 1995-11-02 | Traditional | PDF ↗ |
| K954643 | TRY-IN GEL | Sybron Dental Specialties, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K954177 | ALPHA-BOND DENTIN BONDING SYSTEM | Alpha-Bond, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K953301 | DENTASTIC ONE-STEP | Pulpdent Corp. | 1995-08-25 | Traditional | PDF ↗ |
| K953272 | PULPDENT DENTASTIC II | Pulpdent Corp. | 1995-08-25 | Traditional | PDF ↗ |
| K952960 | PULPDENT POST CEMENT | Pulpdent Corp. | 1995-07-19 | Traditional | PDF ↗ |
| K952121 | 3M RESIN CEMENT | 3M Medical Products Group | 1995-06-22 | Traditional | PDF ↗ |
| K951270 | PULPDENT GLASS IONOMER CEMENTS | Pulpdent Corp. | 1995-05-31 | Traditional | PDF ↗ |
| K951555 | FUJI IX | GC America, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K945451 | HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE | Shofu Dental Corp. | 1995-02-27 | Traditional | PDF ↗ |
| K950428 | VIVAGLASS BASE | Ivoclar North America, Inc. | 1995-02-17 | Traditional | PDF ↗ |
| K950060 | PROVILINK | Ivoclar North America, Inc. | 1995-02-10 | Traditional | PDF ↗ |
| K945366 | PARAPOST CEMENT | Coltene/Whaledent, Inc. | 1995-02-02 | Traditional | PDF ↗ |
| K946137 | PULPDENT PERIODONTAL DRESSINGS | Pulpdent Corp. | 1995-01-26 | Traditional | PDF ↗ |
| K946100 | FUJI DUET | GC America, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K945244 | PULP CANAL SEALER EWT | Sybron Dental Specialties, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K942808 | TYPE I GLASS IONOMER CEMENT | Mion International Corp. | 1994-11-03 | Traditional | PDF ↗ |
| K944480 | SEALAPEX | Sybron Dental Specialties, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K926376 | MION 525 | Mion International Corp. | 1994-10-21 | Traditional | PDF ↗ |
| K940914 | NEW LUTING CEMENT MATERIAL (NLC) | Dentsply Intl. | 1994-08-29 | Traditional | PDF ↗ |
| K942665 | ORTHOCENT: LIQUID AND POWDER | Dentauraum, Inc. | 1994-07-22 | Traditional | PDF ↗ |
| K942596 | ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT | Wallace A. Erickson & Co. | 1994-06-16 | Traditional | PDF ↗ |
| K941065 | DEOX, OXYGEN BARRIER VISCOUS SOLUTION | Ultradent Products, Inc. | 1994-06-16 | Traditional | PDF ↗ |
| K935436 | ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED | Wallace A. Erickson & Co. | 1994-06-10 | Traditional | PDF ↗ |
| K940122 | HY BOND, GLASIONOMER CX | Shofu Dental Corp. | 1994-05-02 | Traditional | PDF ↗ |
| K940546 | GRANITEC IONOMER RESIN CEMENT | Confi-Dental Products Co. | 1994-04-29 | Traditional | PDF ↗ |
| K940459 | MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) | Dentsply Intl. | 1994-04-29 | Traditional | PDF ↗ |
| K933030 | PANAVIA 21 | Kuraray Co. | 1994-02-24 | Traditional | PDF ↗ |
| K933612 | JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) | Jedental Co., Inc. | 1994-02-24 | Traditional | PDF ↗ |
| K940030 | BISCO COMPOSITE | Bisco, Inc. | 1994-02-04 | Traditional | PDF ↗ |
| K922250 | FLEXI-FLOW CEMENT WITH TITANIUM | Essential Dental Systems, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K922249 | FLEXI-FLOW CEMENT NATURAL | Essential Dental Systems, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K934073 | JEDENTAL GLASS IONOMER CEMENT AND LINER | Jedental Co., Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K934405 | PRECEDENT | Reliance Orthodontic Products, Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K935521 | GC ELITE CEMENT | GC America, Inc. | 1994-01-06 | Traditional | PDF ↗ |
| K933199 | CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL | Confi-Dental Products Co. | 1994-01-06 | Traditional | PDF ↗ |
| K933139 | 3M VITREMER LUTING CEMENT | 3M Company | 1994-01-05 | Traditional | PDF ↗ |
| K934184 | FASTFIL | Scientific Pharmaceuticals, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K933554 | JEDENTAL ZINC CEMENT IMPROVED | Jedental Co., Inc. | 1993-11-01 | Traditional | PDF ↗ |
| K933543 | ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) | Jedental Co., Inc. | 1993-11-01 | Traditional | PDF ↗ |
| K933459 | RESIMENT WITH FLUORIDE | J.L. Blosser, Inc. | 1993-10-20 | Traditional | PDF ↗ |
| K925207 | GLASS IONOMER CEMENT | Milton Hodosh, M.D. | 1993-07-08 | Traditional | PDF ↗ |
| K924132 | E.Z. TEMEP, TEMPORARY FILLING MATERIAL | Cosmedent, Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K931229 | VARIGLASS VLC GLASS IONOMER | Dentsply Intl. | 1993-07-08 | Traditional | PDF ↗ |
| K925027 | PHOTAC-FIL APLICAP | Espe GmbH (Us) | 1993-06-18 | Traditional | PDF ↗ |
| K930116 | LCL 8 | Voco GmbH | 1993-06-17 | Traditional | PDF ↗ |
| K931084 | TEMPIT | Centrix, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K923473 | MULTIPURPOSE RESIN CEMENT | Dentsply Intl. | 1993-04-12 | Traditional | PDF ↗ |
| K930455 | CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER | Voco GmbH | 1993-04-08 | Traditional | PDF ↗ |
| K926492 | ARGION DENTAL CEMENT | Voco GmbH | 1993-04-08 | Traditional | PDF ↗ |
| K926458 | BIFIX DENTAL CEMENT | Voco GmbH | 1993-03-31 | Traditional | PDF ↗ |
| K925713 | VITA CEREC DUO CEMENT | Vident | 1993-02-17 | Traditional | PDF ↗ |
| K925032 | 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM | 3M Company | 1992-12-23 | Traditional | PDF ↗ |
| K921173 | TYPE 1 DENTAL CEMENT | Centrix, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K923328 | VENEER CEMENT | Dentsply Intl. | 1992-09-09 | Traditional | PDF ↗ |
| K922638 | TEMPIT-E | Centrix, Inc. | 1992-08-10 | Traditional | PDF ↗ |
| K922853 | AQUA IONOFIL | Voco GmbH | 1992-08-10 | Traditional | PDF ↗ |
| K922854 | AQUA MERON | Voco GmbH | 1992-08-05 | Traditional | PDF ↗ |
| K915666 | AMALCODEN | Mion International Corp. | 1992-03-25 | Traditional | PDF ↗ |
| K914318 | GLASS IONOMER CEMENT | Confi-Dental Products Co. | 1992-03-20 | Traditional | PDF ↗ |
| K915619 | IONOFIL/LONOFIL MOLAR | Voco GmbH | 1992-02-25 | Traditional | PDF ↗ |
| K915618 | PROVICOL | Voco GmbH | 1992-02-25 | Traditional | PDF ↗ |
| K915467 | CIMPAT S DENTAL CEMENT | Specialites Septodont | 1992-02-03 | Traditional | PDF ↗ |
| K914612 | MERON DENTAL CEMENT | Voco GmbH | 1992-02-03 | Traditional | PDF ↗ |
| K915005 | PHOTAC-BOND APLICAP, MODIFICATION | Espe GmbH (Us) | 1992-01-14 | Traditional | PDF ↗ |
| K911061 | ESPE KETAC-ENDO APLICAP | H.A. Opotow Consulting | 1992-01-03 | Traditional | PDF ↗ |
| K914324 | CAVITY VARNISH PRODUCT | Confi-Dental Products Co. | 1991-12-27 | Traditional | PDF ↗ |
| K913519 | SUMO GLASS IONOMER CEMENT | Ortho Source | 1991-11-19 | Traditional | PDF ↗ |
| K913884 | FUJI II LC | G-C Intl. Corp. | 1991-10-30 | Traditional | PDF ↗ |
| K914073 | F21(R) DENTAL CEMENT | Voco GmbH | 1991-10-21 | Traditional | PDF ↗ |
| K913836 | VLC GLASS IONOMER | Dentsply Intl. | 1991-10-17 | Traditional | PDF ↗ |
| K913572 | AUTOPACK NON-EUGENOL PERIODONTAL DRESSING | Specialites Septodont | 1991-10-09 | Traditional | PDF ↗ |
| K912497 | IONOBOND | Voco GmbH | 1991-07-30 | Traditional | PDF ↗ |
| K911842 | 3M LUTING CEMENT, PASTE A AND B | 3M Company | 1991-06-17 | Traditional | PDF ↗ |
| K910719 | SILICOATER MD | Kulzer, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K910424 | TEETHMATE-F | Kuraray Co. | 1991-04-03 | Traditional | PDF ↗ |
| K904034 | TEMPORARY DENTAL CEMENT | Medical Device Inspection Co., Inc. | 1990-12-27 | Traditional | PDF ↗ |
| K904024 | CEMPER | Scientific Pharmaceuticals, Inc. | 1990-11-09 | Traditional | PDF ↗ |
| K901524 | CHEMFIL II CAPS | Dentsply Intl. | 1990-09-19 | Traditional | PDF ↗ |
| K902817 | SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST | Confi-Dental Products Co. | 1990-08-28 | Traditional | PDF ↗ |
| K902392 | COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL | Coltene, Inc. | 1990-08-28 | Traditional | PDF ↗ |
| K902078 | ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY. | Crx Medical, Inc. | 1990-08-03 | Traditional | PDF ↗ |
| K902894 | POST CEMENT (DENTAL COMPOSITE) | Medical Device Inspection Co., Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K902052 | AHYDRON DENTAL CLEANING AGENT | Ivoclar North America, Inc. | 1990-07-13 | Traditional | PDF ↗ |
| K902635 | MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS | Confi-Dental Products Co. | 1990-07-10 | Traditional | PDF ↗ |
| K901082 | CYANODONT DENTAL CEMENT | Specialites Septodont | 1990-07-09 | Traditional | PDF ↗ |
Product code EMA · Class II · Dental. Data: openFDA.