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 2 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111855 | HY-BOND RESIGLASS | Shofu Dental Corp. | 2011-11-17 | Traditional | PDF ↗ |
| K111836 | PERMASHADE VENEER CEMENT | Ultradent Products, Inc. | 2011-09-16 | Traditional | PDF ↗ |
| K111685 | IP TEMP CEMENT | Shofu Dental Corporation | 2011-09-02 | Traditional | PDF ↗ |
| K111017 | CLEARTEMP | Ultradent Products, Inc. | 2011-06-06 | Traditional | PDF ↗ |
| K110508 | SUGLUE-10 | 3M Espe AG | 2011-06-03 | Traditional | PDF ↗ |
| K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products | 2011-05-05 | Traditional | PDF ↗ |
| K103585 | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP | Harry J. Bosworth Co. | 2011-03-04 | Traditional | PDF ↗ |
| K102612 | VOCO IONOFIL MOLAR AC QUICK | Voco GmbH | 2010-11-19 | Traditional | PDF ↗ |
| K101504 | TI-CORE FLOW | Essential Dental Systems, Inc. | 2010-10-29 | Traditional | PDF ↗ |
| K101787 | DUOLINK II | Bisco, Inc. | 2010-10-08 | Traditional | PDF ↗ |
| K101869 | PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) | Silmet , Ltd. | 2010-09-29 | Traditional | PDF ↗ |
| K101420 | GC FUJI TEMP | GC America, Inc. | 2010-09-17 | Traditional | PDF ↗ |
| K101493 | ADVANCED GLASS IONOMER (K-130) RESTORATIVE | Dentsply International, Inc. | 2010-08-19 | Traditional | PDF ↗ |
| K100247 | DETAX IMPLANTLINK SEMI | Detax GmbH & Co. KG | 2010-07-23 | Traditional | PDF ↗ |
| K100908 | UNICEM HM | 3M Espe AG Dental Products | 2010-06-22 | Traditional | PDF ↗ |
| K101044 | RETRIEVE IMPLANT CEMENT | Parkell, Inc. | 2010-06-10 | Traditional | PDF ↗ |
| K100756 | MALTA | 3M Espe AG Dental Products | 2010-06-02 | Traditional | PDF ↗ |
| K094007 | UNICEM | 3M Espe AG Dental Products | 2010-04-08 | Traditional | PDF ↗ |
| K100510 | CERAMIR CROWN & BRIDGE | Doxa AB | 2010-03-25 | Special | PDF ↗ |
| K100290 | ESTEMP NE | Spident Co., Ltd. | 2010-02-17 | Traditional | PDF ↗ |
| K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | Dmg USA, Inc. | 2010-02-12 | Abbreviated | PDF ↗ |
| K091735 | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT | S & C Polymer GmbH | 2009-09-25 | Traditional | PDF ↗ |
| K090817 | IONOLUX | Voco GmbH | 2009-07-23 | Traditional | PDF ↗ |
| K091106 | EQUIA | GC America, Inc. | 2009-06-17 | Traditional | PDF ↗ |
| K091019 | SPEEDCEM | Ivoclar Vivadent, Inc. | 2009-06-04 | Traditional | PDF ↗ |
| K083766 | PHOGLASS CEM | S & C Polymer GmbH | 2009-03-02 | Traditional | PDF ↗ |
| K083516 | PERIOGENIX | Oroscience, Inc. | 2009-02-20 | Traditional | PDF ↗ |
| K083438 | BIFIX SE | Voco GmbH | 2009-02-13 | Traditional | PDF ↗ |
| K083304 | TEMPOSIL 2 | Coltene/Whaledent AG | 2009-02-06 | Traditional | PDF ↗ |
| K083398 | CERCOM CEMENT | Denali R&D Corporation | 2009-01-26 | Traditional | PDF ↗ |
| K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | S & C Polymer GmbH | 2009-01-15 | Traditional | PDF ↗ |
| K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 | Bisco, Inc. | 2008-09-25 | Special | PDF ↗ |
| K081702 | CARBOXYLATE CEM, PHOSPHATE CEM | S & C Polymer GmbH | 2008-09-05 | Traditional | PDF ↗ |
| K081913 | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER | Meta Biomed Co., Ltd. | 2008-09-05 | Traditional | PDF ↗ |
| K081887 | LUTE-IT II VENEER CEMENT, MODEL NO6 | Pentron Clinical Technologies | 2008-08-29 | Traditional | PDF ↗ |
| K081405 | XERACEM | Doxa Dental AB | 2008-08-21 | Abbreviated | PDF ↗ |
| K081583 | CLEARFIL SA CEMENT | Kuraray Medical, Inc. | 2008-07-28 | Traditional | PDF ↗ |
| K080517 | RESICEM | Shofu Dental Corp. | 2008-06-11 | Traditional | PDF ↗ |
| K080768 | ULTRATEMP FIRM, FAST AND REGULAR SET | Ultradent Products, Inc. | 2008-04-11 | Special | PDF ↗ |
| K073698 | SECURE | Parkell, Inc. | 2008-03-19 | Traditional | PDF ↗ |
| K073283 | GC GAM-100 | GC America, Inc. | 2008-02-20 | Traditional | PDF ↗ |
| K073173 | SELF-ADHESIVE RESIN CEMENT | Dentsply Interntional | 2008-01-23 | Traditional | PDF ↗ |
| K073101 | AURAVENEER CEMENT | Denali Corporation | 2008-01-17 | Traditional | PDF ↗ |
| K073395 | GILB-2, GLASS IONOMER PROTECTIVE COATING | 3M Espe Dental Products | 2008-01-17 | Traditional | PDF ↗ |
| K073043 | SET PP | Sdi , Ltd. | 2007-12-14 | Traditional | PDF ↗ |
| K072604 | DUO TEMP | Coltene/Whaledent AG | 2007-11-16 | Traditional | PDF ↗ |
| K071484 | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 | Glustitch, Inc. | 2007-10-10 | Traditional | PDF ↗ |
| K070840 | GVC-100 | GC America, Inc. | 2007-05-15 | Traditional | PDF ↗ |
| K070319 | GC FUJI IX GP EXTRA | GC America, Inc. | 2007-02-26 | Special | PDF ↗ |
| K063554 | MERON PLUS | Voco GmbH | 2007-01-12 | Abbreviated | PDF ↗ |
| K062355 | ENA CEM | Micerium S.P.A. | 2006-12-27 | Traditional | PDF ↗ |
| K062065 | RIVA LUTING PLUS | Southern Dental Industries, Inc. | 2006-11-15 | Traditional | PDF ↗ |
| K062064 | RIVA BOND LC | Southern Dental Industries, Inc. | 2006-11-09 | Traditional | PDF ↗ |
| K062292 | UNICEM | 3M Espe Dental Products | 2006-10-25 | Traditional | PDF ↗ |
| K062519 | NEXUS 3 | Kerr Corporation | 2006-10-19 | Traditional | PDF ↗ |
| K062410 | CLEARFIL ESTHETIC CEMENT & DC BOND | Kuraray Medical, Inc. | 2006-09-26 | Traditional | PDF ↗ |
| K061781 | MULTILINK SPRINT | Ivoclar Vivadent, Inc. | 2006-09-05 | Traditional | PDF ↗ |
| K061535 | GC XLC-100 CAPSULE | GC America, Inc. | 2006-07-14 | Traditional | PDF ↗ |
| K060701 | BISCEM TRANSLUCENT, BISCEM OPAQUE | Bisco, Inc. | 2006-05-15 | Traditional | PDF ↗ |
| K060698 | CEMENT-IT ALL PURPOSE, MODEL N97 | Pentron Clinical Technologies | 2006-05-10 | Traditional | PDF ↗ |
| K060894 | BIFIX QM | Voco GmbH | 2006-05-02 | Special | PDF ↗ |
| K060334 | GI DENTSTAT | Ultradent Products, Inc. | 2006-02-23 | Abbreviated | PDF ↗ |
| K053565 | TEMPBOND CLEAR WITH TRICLOSAN | Sybron Dental Specialties, Inc. | 2006-02-03 | Traditional | PDF ↗ |
| K053040 | PARACEM UNIVERSAL DC | Coltene/Whaledent AG | 2005-11-09 | Traditional | PDF ↗ |
| K052235 | LCR | 3M Company | 2005-09-27 | Special | PDF ↗ |
| K051952 | EUGENONE | Scientific Pharmaceuticals, Inc. | 2005-09-07 | Traditional | PDF ↗ |
| K051866 | PREMIER TEMPORARY CEMENT | Premier Dental Products Co. | 2005-09-06 | Traditional | PDF ↗ |
| K051427 | GC FUJI FIL LC | GC America, Inc. | 2005-08-22 | Traditional | PDF ↗ |
| K051008 | SET | Southern Dental Industries, Ltd. | 2005-06-15 | Traditional | PDF ↗ |
| K050870 | RIVA LIGHT CURE | Southern Dental Industries, Inc. | 2005-06-03 | Traditional | PDF ↗ |
| K050658 | RESO-PAC PERIODONTAL DRESSING | Hager Worldwide, Inc. | 2005-05-27 | Traditional | PDF ↗ |
| K050426 | TEMPOSIL, MODEL 6720 | Coltene/Whaledent AG | 2005-03-18 | Traditional | PDF ↗ |
| K042846 | SYSTEMP.LINK | Ivoclar Vivadent, Inc. | 2004-12-20 | Traditional | PDF ↗ |
| K042847 | SYSTEMP.CEM | Ivoclar Vivadent, Inc. | 2004-12-17 | Traditional | PDF ↗ |
| K042452 | RIVA SILVER | Southern Dental Industries, Inc. | 2004-12-07 | Traditional | PDF ↗ |
| K042669 | IONOFIL PLUS AC | Voco GmbH | 2004-10-20 | Special | PDF ↗ |
| K041272 | DYRACT CEM PLUS CEMENT | Dentsply Intl. | 2004-10-18 | Traditional | PDF ↗ |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Premier Dental Products Co. | 2004-09-21 | Traditional | PDF ↗ |
| K040343 | TEMP F | Novocol, Inc. | 2004-08-03 | Traditional | PDF ↗ |
| K041474 | MAXCEM | Sybron Dental Specialties, Inc. | 2004-07-21 | Traditional | PDF ↗ |
| K040906 | CALIBRA CEMENT | Dentsply Intl. | 2004-06-16 | Traditional | PDF ↗ |
| K040895 | INTEGRITY TEMPORARY CEMENT | Dentsply Intl. | 2004-05-21 | Traditional | PDF ↗ |
| K040393 | RIVA LUTING | Southern Dental Industries, Inc. | 2004-04-30 | Traditional | PDF ↗ |
| K040236 | PULPDENT VLC RESIN CEMENT | Pulpdent Corporation | 2004-04-20 | Traditional | PDF ↗ |
| K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | Premier Dental Products Co. | 2004-01-26 | Traditional | PDF ↗ |
| K031494 | DOC'S BEST WHITE COPPER CEMENT | Cooley & Cooley, Ltd. | 2003-11-12 | Traditional | PDF ↗ |
| K032455 | PANAVIA F 2.0 | Kuraray Medical, Inc. | 2003-11-07 | Traditional | PDF ↗ |
| K032470 | MULTILINK | Ivoclar Vivadent, Inc. | 2003-11-05 | Traditional | PDF ↗ |
| K032597 | BISCEM GI | Bisco, Inc. | 2003-11-04 | Traditional | PDF ↗ |
| K033068 | IONOFIL COLOR AC | Voco GmbH | 2003-10-31 | Traditional | PDF ↗ |
| K032175 | DESENS-IONOMER | Milton Hodosh, M.D. | 2003-10-09 | Traditional | PDF ↗ |
| K031752 | COLTOSOL F | Coltene/Whaledent, Inc. | 2003-08-05 | Traditional | PDF ↗ |
| K031467 | GLASIONOMER FX-II | Shofu Dental Corp. | 2003-07-17 | Traditional | PDF ↗ |
| K031212 | TEMPORARY RESIN CEMENT | Parkell, Inc. | 2003-07-11 | Traditional | PDF ↗ |
| K030727 | POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT | Healex Products, Inc. | 2003-06-05 | Traditional | PDF ↗ |
| K030516 | RIVA-SELF CURE | Southern Dental Industries, Inc. | 2003-04-17 | Traditional | PDF ↗ |
| K024287 | FIXOBRIDGE 3-CEMENT | Advanced Healthcare , Ltd. | 2003-03-21 | Traditional | PDF ↗ |
| K030168 | AGC CEM | Wieland Dental + Technik GmbH & Co. KG | 2003-03-21 | Traditional | PDF ↗ |
| K023888 | CIMOFLUOR | Global Dental Products, Inc. | 2003-03-05 | Traditional | PDF ↗ |
| K023981 | AHL GENERIC GLASS IONOMER LUTING CEMENT | Advanced Healthcare , Ltd. | 2003-01-31 | Traditional | PDF ↗ |
Product code EMA · Class II · Dental. Data: openFDA.