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 3 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023649 | VITIQUE SYSTEM | Dmg USA, Inc. | 2003-01-17 | Abbreviated | PDF ↗ |
| K023727 | TEMPORARY CEMENT-DC010002 | GC America, Inc. | 2003-01-16 | Traditional | PDF ↗ |
| K022150 | TRIONOMER | Pentron Clinical Technologies | 2002-08-21 | Traditional | PDF ↗ |
| K022476 | RELYX RMGIP | 3M Company | 2002-08-02 | Special | PDF ↗ |
| K021038 | GC ELITE CEMENT 100 | GC America, Inc. | 2002-05-03 | Traditional | PDF ↗ |
| K020481 | PULPDENT POST CEMENT | Pulpdent Corporation | 2002-04-17 | Traditional | PDF ↗ |
| K020376 | AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE | Advanced Healthcare , Ltd. | 2002-04-09 | Traditional | PDF ↗ |
| K020256 | UNICEM | 3M Espe AG Dental Products | 2002-03-25 | Traditional | PDF ↗ |
| K020117 | GC FUJI LINING LC PASTE PAK | GC America, Inc. | 2002-02-28 | Traditional | PDF ↗ |
| K013555 | SCI-PHARM POST SECURE | Scientific Pharmaceuticals, Inc. | 2002-01-23 | Traditional | PDF ↗ |
| K013609 | NEXUS 2 CLEAR | Sybron Dental Specialties, Inc. | 2002-01-16 | Traditional | PDF ↗ |
| K013446 | GLUSITE, MODEL GLU002 | Glustitch, Inc. | 2001-12-20 | Traditional | PDF ↗ |
| K013198 | FUJI VII CAPSULE | GC America, Inc. | 2001-10-29 | Traditional | PDF ↗ |
| K013008 | NEXUS 2 MODIFIED | Sybron Dental Specialties, Inc. | 2001-10-02 | Traditional | PDF ↗ |
| K012735 | CLEARFIL DC CEMENT | Kuraray Medical, Inc. | 2001-09-14 | Traditional | PDF ↗ |
| K012441 | PANAVIA F | Kuraray Medical, Inc. | 2001-09-06 | Traditional | PDF ↗ |
| K012438 | MODIFICATION TO PANAVIA 21 | Kuraray Medical, Inc. | 2001-09-05 | Traditional | PDF ↗ |
| K011854 | TOKUYAMA M-BOND | Tokuyama America, Inc. | 2001-09-04 | Traditional | PDF ↗ |
| K012316 | PERMACEM / PERMACEM DUAL | Dmg USA, Inc. | 2001-08-23 | Abbreviated | PDF ↗ |
| K011685 | BISTITE II DC | Tokuyama America, Inc. | 2001-07-31 | Traditional | PDF ↗ |
| K010541 | PREVISION CHEM | Heraeus Kulzer, Inc. | 2001-07-31 | Traditional | PDF ↗ |
| K011520 | RESTORE-X | First Scientific Limited | 2001-07-23 | Traditional | PDF ↗ |
| K011200 | GILB, MODEL 8010 | 3M Company | 2001-06-14 | Traditional | PDF ↗ |
| K011431 | RESIN CEM | S & C Polymer GmbH | 2001-06-11 | Traditional | PDF ↗ |
| K011159 | ONE-STEP PLUS | Bisco, Inc. | 2001-06-08 | Traditional | PDF ↗ |
| K011064 | CLASSIC CEM | S & C Polymer GmbH | 2001-05-17 | Traditional | PDF ↗ |
| K010240 | POLYCARBOXYLATE (PCA) CEMENT | Rite-Dent Manufacturing Corp. | 2001-03-27 | Traditional | PDF ↗ |
| K003407 | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) | Ivoclar North America, Inc. | 2001-01-26 | Traditional | PDF ↗ |
| K003921 | DYRACT CEM LCI COMPOMER | Dentsply Intl. | 2001-01-24 | Traditional | PDF ↗ |
| K003427 | ZINC PHOSPHATE CEMENT | Rite-Dent Manufacturing Corp. | 2001-01-24 | Traditional | PDF ↗ |
| K003791 | CAVEX TEMPORARY CEMENT | Cavex Holland BV | 2001-01-23 | Traditional | PDF ↗ |
| K003658 | TEMP-BOND NE 2 | Sybron Dental Specialties, Inc. | 2001-01-04 | Traditional | PDF ↗ |
| K002843 | SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 | Sultan Chemists, Inc. | 2000-11-15 | Traditional | PDF ↗ |
| K002452 | 3M RELY X VENEER CEMENT TRY-IN PASTER | 3M Company | 2000-09-28 | Traditional | PDF ↗ |
| K002793 | KETAC CEM U | Espe Dental AG | 2000-09-26 | Special | PDF ↗ |
| K002461 | HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT | Shofu Dental Corp. | 2000-09-26 | Traditional | PDF ↗ |
| K002322 | MODIFICATION TO PANAVIA F | Kuraray America, Inc. | 2000-09-18 | Traditional | PDF ↗ |
| K001823 | LINKMAX | GC America, Inc. | 2000-08-16 | Traditional | PDF ↗ |
| K001730 | GC FUJICEM | GC America, Inc. | 2000-07-17 | Traditional | PDF ↗ |
| K000173 | CEMENT IT! UNIVERSAL C&B | Jeneric/Pentron, Inc. | 2000-02-29 | Traditional | PDF ↗ |
| K994261 | ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT | Ultradent Products, Inc. | 2000-02-02 | Traditional | PDF ↗ |
| K993556 | LIQUIBAND DENTAL | Medlogic Global Corp. | 2000-01-03 | Traditional | PDF ↗ |
| K993710 | MODIFICATION OF PARAPOST CEMENT | Coltene/Whaledent, Inc. | 1999-12-21 | Traditional | PDF ↗ |
| K993324 | CARBOCEM ZINC POLYCARBOXYLATE CEMENT | Scientific Pharmaceuticals, Inc. | 1999-11-09 | Traditional | PDF ↗ |
| K991974 | FUTURA GLASS IONOMER SILVER REINFORCED | Ab Ardent | 1999-09-17 | Traditional | PDF ↗ |
| K992160 | NEXUS 2 | Sybron Dental Specialties, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K991711 | BISTITE II SC | Tokuyama America, Inc. | 1999-07-07 | Traditional | PDF ↗ |
| K991172 | IONOSIT BOND | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1999-05-17 | Traditional | PDF ↗ |
| K990381 | TOTALBOND | Parkell, Inc. | 1999-05-17 | Traditional | PDF ↗ |
| K990155 | HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 | Kay See Dental Mfg. Co. | 1999-02-25 | Traditional | PDF ↗ |
| K984505 | MIRACLE MIX POWDER/LIQUID | GC America, Inc. | 1999-02-04 | Traditional | PDF ↗ |
| K984248 | PROCEM | Espe Dental AG | 1999-01-08 | Traditional | PDF ↗ |
| K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | Sterngold/Implamed | 1999-01-08 | Abbreviated | PDF ↗ |
| K983752 | ALUMINA-ZINC OXIDE POWDERS F AND R | Harry J. Bosworth Co. | 1998-12-10 | Traditional | PDF ↗ |
| K983361 | PANAVIA F | Kuraray America, Inc. | 1998-11-13 | Traditional | PDF ↗ |
| K982773 | QUICKSET LIQUID AND POWDER | Specialites Septodont | 1998-11-03 | Traditional | PDF ↗ |
| K983018 | ZINC PHOSPHATE CEMENT | Medental Intl. | 1998-10-22 | Traditional | PDF ↗ |
| K982913 | ZINFOS ZINC PHOSPHATE CEMENT | Scientific Pharmaceuticals, Inc. | 1998-10-19 | Traditional | PDF ↗ |
| K982895 | STERNOMEGA COMPOMER CEMENT | Sterngold/Implamed | 1998-10-09 | Traditional | PDF ↗ |
| K982590 | TEMPBOND CLEAR-2 | Sybron Dental Specialties, Inc. | 1998-10-08 | Traditional | PDF ↗ |
| K982779 | MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 | Medental Intl. | 1998-09-30 | Traditional | PDF ↗ |
| K982400 | STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT | Steri-Oss, Inc. | 1998-09-23 | Traditional | PDF ↗ |
| K982665 | JUMBO SILVER-REINFORCED GLASS IONOMER | Centrix, Inc. | 1998-09-08 | Traditional | PDF ↗ |
| K982461 | GLASIONOMER CEMENT CX PLUS | Shofu Dental Corp. | 1998-08-24 | Traditional | PDF ↗ |
| K980990 | POLYCARBOXYLATE CEMENT | Medental Intl. | 1998-07-31 | Traditional | PDF ↗ |
| K981618 | LIQUID A | Harry J. Bosworth Co. | 1998-07-28 | Traditional | PDF ↗ |
| K973636 | MCS-MEDICATED CANAL SEALER | Dr. Howard Martin, P.A. | 1998-07-27 | Traditional | PDF ↗ |
| K981965 | FLOWABLE COMPOSITE | Dentsply Intl. | 1998-07-10 | Traditional | PDF ↗ |
| K981335 | ARISTON PHC LINER | Ivoclar North America, Inc. | 1998-07-02 | Traditional | PDF ↗ |
| K973201 | PROVI CEMENT | S & C Polymer GmbH | 1998-06-05 | Traditional | PDF ↗ |
| K981370 | MIRACLE MIX CAPSULE | GC America, Inc. | 1998-06-01 | Traditional | PDF ↗ |
| K980568 | JUMBO GLASS IONOMER CEMENT | Centrix, Inc. | 1998-04-30 | Traditional | PDF ↗ |
| K980922 | PROTEC CEM. | Ivoclar North America, Inc. | 1998-04-30 | Traditional | PDF ↗ |
| K980695 | FUJI I | GC America, Inc. | 1998-04-13 | Traditional | PDF ↗ |
| K980159 | OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 | Closure Medical Corp. | 1998-04-09 | Traditional | PDF ↗ |
| K974097 | PERIACRYL | Blacklock Medical Products, Inc. | 1998-04-09 | Traditional | PDF ↗ |
| K980682 | FUJI II | GC America, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K980232 | CLEARFIL DC CEMENT | Kuraray Company, Ltd. | 1998-02-24 | Traditional | PDF ↗ |
| K974458 | COMPOLUTE APLICAP | Espe Dental-Medizin GmbH & Co.Kg. | 1998-02-02 | Traditional | PDF ↗ |
| K972935 | SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL | S.S. White Mfg., Ltd. | 1998-01-29 | Traditional | PDF ↗ |
| K974140 | ADHESIVE HYBRID IONOMER CEMENT | Dentsply Intl. | 1998-01-05 | Traditional | PDF ↗ |
| K973961 | 3M DENT SYSTEM II PLUS | 3M Company | 1997-12-17 | Traditional | PDF ↗ |
| K974014 | PULPDENT DENTASTIC UNO | Pulpdent Corp. | 1997-12-17 | Traditional | PDF ↗ |
| K973370 | AQUAPLAST PALATAL STENT | Wfr/Aquaplast Corp. | 1997-12-02 | Traditional | PDF ↗ |
| K973397 | SYNTAC SPRINT | Ivoclar North America, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K973262 | KETAC-FIL APLICAP PLUS | Espe GmbH & Co. Kg. | 1997-11-17 | Traditional | PDF ↗ |
| K972965 | STERI-OSS UNTIL IMPLANT CEMENT | Steri-Oss, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K972844 | TEMP BOND CLEAR | Kerr Dental Materials Center | 1997-10-03 | Traditional | PDF ↗ |
| K972445 | PULPDENT OX-OUT | Pulpdent Corp. | 1997-10-02 | Traditional | PDF ↗ |
| K972485 | CIMPAT N | Arent, Fox, Kintner, Plotkin & Kahn | 1997-09-08 | Traditional | PDF ↗ |
| K971642 | DENTALIS KEZ ENDODONITC SEALER | Neodental Chemical Products Co., Ltd. | 1997-07-24 | Traditional | PDF ↗ |
| K971927 | HI DENSE TC | Shofu Dental Corp. | 1997-06-30 | Traditional | PDF ↗ |
| K970775 | TEMPO CEM (MULTIPLE) | Foremost Dental Mfg., Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K970774 | TEMPOCEM NE (MULTIPLE) | Foremost Dental Mfg., Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K964808 | SPETEMP | Ultradent Products, Inc. | 1997-02-26 | Traditional | PDF ↗ |
| K964773 | DENTEMP ONE STEP | Majestic Drug Co., Inc. | 1997-02-21 | Traditional | PDF ↗ |
| K964809 | SPETEMP EF | Ultradent Products, Inc. | 1997-01-02 | Traditional | PDF ↗ |
| K963737 | HYCEM APLICAP | Espe GmbH & Co. Kg. | 1996-11-15 | Traditional | PDF ↗ |
| K962733 | CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920) | Union Broach, Div. Moyco Industries, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K962747 | PULPDENT ENDODONTIC POST CEMENT KIT | Pulpdent Corp. | 1996-09-30 | Traditional | PDF ↗ |
Product code EMA · Class II · Dental. Data: openFDA.