Cement, Dental
Regulation 872.3275
10510(k)s in 12 months (509 all time)
0recalls in 12 months (16 all time)
13recalls that name a 510(k)
Top companies in EMA
| Company | 510(k)s | Recalls |
|---|---|---|
| GC America, Inc. | 30 | 0 |
| Voco GmbH | 26 | 2 |
| Shofu Dental Corp. | 24 | 0 |
| Dentsply Intl. | 19 | 0 |
| Pulpdent Corp. | 14 | 0 |
| Sybron Dental Specialties | 14 | 0 |
| 3M Company | 12 | 0 |
| Bisco, Inc. | 9 | 2 |
| Espe GmbH (Us) | 10 | 0 |
| Coltene/Whaledent AG | 9 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 27, 2006 | K062355 | ENA CEM Micerium S.P.A., IT | EMA |
| Nov 15, 2006 | K062065 | RIVA LUTING PLUS Southern Dental Industries, Inc. | EMA |
| Nov 9, 2006 | K062064 | RIVA BOND LC Southern Dental Industries, Inc. | EMA |
| Oct 25, 2006 | K062292 | UNICEM 3M Espe Dental Products, DE | EMA |
| Oct 19, 2006 | K062519 | NEXUS 3 Kerr Corporation | EMA |
| Sep 26, 2006 | K062410 | CLEARFIL ESTHETIC CEMENT & DC BOND Kuraray Medical, Inc. | EMA |
| Sep 5, 2006 | K061781 | MULTILINK SPRINT Ivoclar Vivadent, Inc. | EMA |
| Jul 14, 2006 | K061535 | GC XLC-100 CAPSULE GC America, Inc. | EMA |
| May 15, 2006 | K060701 | BISCEM TRANSLUCENT, BISCEM OPAQUE Bisco, Inc. | EMA |
| May 10, 2006 | K060698 | CEMENT-IT ALL PURPOSE, MODEL N97 Pentron Clinical Technologies | EMA |
| May 2, 2006 | K060894 | BIFIX QM Voco GmbH, DE | EMA |
| Feb 23, 2006 | K060334 | GI DENTSTAT Ultradent Products, Inc. | EMA |
| Feb 3, 2006 | K053565 | TEMPBOND CLEAR WITH TRICLOSAN Sybron Dental Specialties, Inc. | EMA |
| Nov 9, 2005 | K053040 | PARACEM UNIVERSAL DC Coltene/Whaledent AG | EMA |
| Sep 27, 2005 | K052235 | LCR 3M Company | EMA |
| Sep 7, 2005 | K051952 | EUGENONE Scientific Pharmaceuticals, Inc. | EMA |
| Sep 6, 2005 | K051866 | PREMIER TEMPORARY CEMENT Premier Dental Products Co. | EMA |
| Aug 22, 2005 | K051427 | GC FUJI FIL LC GC America, Inc. | EMA |
| Jun 15, 2005 | K051008 | SET Southern Dental Industries, Ltd. | EMA |
| Jun 3, 2005 | K050870 | RIVA LIGHT CURE Southern Dental Industries, Inc., AU | EMA |
| May 27, 2005 | K050658 | RESO-PAC PERIODONTAL DRESSING Hager Worldwide, Inc. | EMA |
| Mar 18, 2005 | K050426 | TEMPOSIL, MODEL 6720 Coltene/Whaledent AG | EMA |
| Dec 20, 2004 | K042846 | SYSTEMP.LINK Ivoclar Vivadent, Inc. | EMA |
| Dec 17, 2004 | K042847 | SYSTEMP.CEM Ivoclar Vivadent, Inc. | EMA |
| Dec 7, 2004 | K042452 | RIVA SILVER Southern Dental Industries, Inc. | EMA |
| Oct 20, 2004 | K042669 | IONOFIL PLUS AC Voco GmbH | EMA |
| Oct 18, 2004 | K041272 | DYRACT CEM PLUS CEMENT Dentsply Intl. | EMA |
| Sep 21, 2004 | K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT Premier Dental Products Co. | EMA |
| Aug 3, 2004 | K040343 | TEMP F Novocol, Inc. | EMA |
| Jul 21, 2004 | K041474 | MAXCEM Sybron Dental Specialties, Inc. | EMA |
| Jun 16, 2004 | K040906 | CALIBRA CEMENT Dentsply Intl. | EMA |
| May 21, 2004 | K040895 | INTEGRITY TEMPORARY CEMENT Dentsply Intl. | EMA |
| Apr 30, 2004 | K040393 | RIVA LUTING Southern Dental Industries, Inc. | EMA |
| Apr 20, 2004 | K040236 | PULPDENT VLC RESIN CEMENT Pulpdent Corporation | EMA |
| Jan 26, 2004 | K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 Premier Dental Products Co. | EMA |
| Nov 12, 2003 | K031494 | DOC'S BEST WHITE COPPER CEMENT Cooley & Cooley, Ltd. | EMA |
| Nov 7, 2003 | K032455 | PANAVIA F 2.0 Kuraray Medical, Inc. | EMA |
| Nov 5, 2003 | K032470 | MULTILINK Ivoclar Vivadent, Inc. | EMA |
| Nov 4, 2003 | K032597 | BISCEM GI Bisco, Inc. | EMA |
| Oct 31, 2003 | K033068 | IONOFIL COLOR AC Voco GmbH | EMA |
| Oct 9, 2003 | K032175 | DESENS-IONOMER Milton Hodosh, M.D. | EMA |
| Aug 5, 2003 | K031752 | COLTOSOL F Coltene/Whaledent, Inc. | EMA |
| Jul 17, 2003 | K031467 | GLASIONOMER FX-II Shofu Dental Corp. | EMA |
| Jul 11, 2003 | K031212 | TEMPORARY RESIN CEMENT Parkell, Inc. | EMA |
| Jun 5, 2003 | K030727 | POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT Healex Products, Inc. | EMA |
| Apr 17, 2003 | K030516 | RIVA-SELF CURE Southern Dental Industries, Inc. | EMA |
| Mar 21, 2003 | K030168 | AGC CEM Wieland Dental + Technik GmbH & Co. KG, DE | EMA |
| Mar 21, 2003 | K024287 | FIXOBRIDGE 3-CEMENT Advanced Healthcare , Ltd. | EMA |
| Mar 5, 2003 | K023888 | CIMOFLUOR Global Dental Products, Inc. | EMA |
| Jan 31, 2003 | K023981 | AHL GENERIC GLASS IONOMER LUTING CEMENT Advanced Healthcare , Ltd. | EMA |
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