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 |
|---|---|---|---|
| Nov 17, 2011 | K111855 | HY-BOND RESIGLASS Shofu Dental Corp. | EMA |
| Sep 16, 2011 | K111836 | PERMASHADE VENEER CEMENT Ultradent Products, Inc. | EMA |
| Sep 2, 2011 | K111685 | IP TEMP CEMENT Shofu Dental Corporation | EMA |
| Jun 6, 2011 | K111017 | CLEARTEMP Ultradent Products, Inc. | EMA |
| Jun 3, 2011 | K110508 | SUGLUE-10 3M Espe AG, DE | EMA |
| May 5, 2011 | K111185 | RELYX LUTING PLUS AUTOMIX 3M Espe Dental Products | EMA |
| Mar 4, 2011 | K103585 | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP Harry J. Bosworth Co. | EMA |
| Nov 19, 2010 | K102612 | VOCO IONOFIL MOLAR AC QUICK Voco GmbH, DE | EMA |
| Oct 29, 2010 | K101504 | TI-CORE FLOW Essential Dental Systems, Inc. | EMA |
| Oct 8, 2010 | K101787 | DUOLINK II Bisco, Inc. | EMA |
| Sep 29, 2010 | K101869 | PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) Silmet , Ltd., IL | EMA |
| Sep 17, 2010 | K101420 | GC FUJI TEMP GC America, Inc. | EMA |
| Aug 19, 2010 | K101493 | ADVANCED GLASS IONOMER (K-130) RESTORATIVE Dentsply International, Inc. | EMA |
| Jul 23, 2010 | K100247 | DETAX IMPLANTLINK SEMI Detax GmbH & Co. KG, NL | EMA |
| Jun 22, 2010 | K100908 | UNICEM HM 3M Espe AG Dental Products, DE | EMA |
| Jun 10, 2010 | K101044 | RETRIEVE IMPLANT CEMENT Parkell, Inc. | EMA |
| Jun 2, 2010 | K100756 | MALTA 3M Espe AG Dental Products, DE | EMA |
| Apr 8, 2010 | K094007 | UNICEM 3M Espe AG Dental Products, DE | EMA |
| Mar 25, 2010 | K100510 | CERAMIR CROWN & BRIDGE Doxa AB, SE | EMA |
| Feb 17, 2010 | K100290 | ESTEMP NE Spident Co., Ltd., KR | EMA |
| Feb 12, 2010 | K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT Dmg USA, Inc. | EMA |
| Sep 25, 2009 | K091735 | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT S & C Polymer GmbH, DE | EMA |
| Jul 23, 2009 | K090817 | IONOLUX Voco GmbH, DE | EMA |
| Jun 17, 2009 | K091106 | EQUIA GC America, Inc. | EMA |
| Jun 4, 2009 | K091019 | SPEEDCEM Ivoclar Vivadent, Inc. | EMA |
| Mar 2, 2009 | K083766 | PHOGLASS CEM S & C Polymer GmbH, DE | EMA |
| Feb 20, 2009 | K083516 | PERIOGENIX Oroscience, Inc. | EMA |
| Feb 13, 2009 | K083438 | BIFIX SE Voco GmbH, DE | EMA |
| Feb 6, 2009 | K083304 | TEMPOSIL 2 Coltene/Whaledent AG | EMA |
| Jan 26, 2009 | K083398 | CERCOM CEMENT Denali R&D Corporation | EMA |
| Jan 15, 2009 | K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT S & C Polymer GmbH, DE | EMA |
| Sep 25, 2008 | K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 Bisco, Inc. | EMA |
| Sep 5, 2008 | K081913 | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER Meta Biomed Co., Ltd., KR | EMA |
| Sep 5, 2008 | K081702 | CARBOXYLATE CEM, PHOSPHATE CEM S & C Polymer GmbH, DE | EMA |
| Aug 29, 2008 | K081887 | LUTE-IT II VENEER CEMENT, MODEL NO6 Pentron Clinical Technologies | EMA |
| Aug 21, 2008 | K081405 | XERACEM Doxa Dental AB | EMA |
| Jul 28, 2008 | K081583 | CLEARFIL SA CEMENT Kuraray Medical, Inc. | EMA |
| Jun 11, 2008 | K080517 | RESICEM Shofu Dental Corp. | EMA |
| Apr 11, 2008 | K080768 | ULTRATEMP FIRM, FAST AND REGULAR SET Ultradent Products, Inc. | EMA |
| Mar 19, 2008 | K073698 | SECURE Parkell, Inc. | EMA |
| Feb 20, 2008 | K073283 | GC GAM-100 GC America, Inc. | EMA |
| Jan 23, 2008 | K073173 | SELF-ADHESIVE RESIN CEMENT Dentsply Interntional | EMA |
| Jan 17, 2008 | K073395 | GILB-2, GLASS IONOMER PROTECTIVE COATING 3M Espe Dental Products | EMA |
| Jan 17, 2008 | K073101 | AURAVENEER CEMENT Denali Corporation | EMA |
| Dec 14, 2007 | K073043 | SET PP Sdi , Ltd., AU | EMA |
| Nov 16, 2007 | K072604 | DUO TEMP Coltene/Whaledent AG | EMA |
| Oct 10, 2007 | K071484 | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 Glustitch, Inc., CA | EMA |
| May 15, 2007 | K070840 | GVC-100 GC America, Inc. | EMA |
| Feb 26, 2007 | K070319 | GC FUJI IX GP EXTRA GC America, Inc. | EMA |
| Jan 12, 2007 | K063554 | MERON PLUS Voco GmbH, DE | EMA |
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