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 |
|---|---|---|---|
| Apr 2, 2018 | K172382 | GC Fuji Direct GC America, Inc. | EMA |
| Mar 14, 2017 | K162960 | TotalC-Ram Itena Clinical, FR | EMA |
| Mar 3, 2017 | K160345 | Glass Ionomer Cement Shandong Huge Dental Material Corporation, CN | EMA |
| Feb 6, 2017 | K170330 | 3M Protemp Cement Temporary Dental Cement 3M Company | EMA |
| Nov 16, 2016 | K160800 | DuoCem Coltene/Whaledent AG, CH | EMA |
| Oct 31, 2016 | K161851 | Glass Ionomer Cement (Luting) Shandong Huge Dental Material Corporation, CN | EMA |
| Sep 30, 2016 | K160443 | TempoCem Clear Dmg USA, Inc. | EMA |
| Aug 3, 2016 | K160774 | IonoStar Plus Voco GmbH, DE | EMA |
| Jul 29, 2016 | K161256 | TheraCem Bisco, Inc. | EMA |
| Jul 6, 2016 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer GC America, Inc. | EMA |
| Jun 6, 2016 | K142130 | ORAL BOND Steiner Laboratories | EMA |
| Apr 13, 2016 | K153174 | Ketac Universal Aplicap 3M Deutschland GmbH, DE | EMA |
| Apr 5, 2016 | K152652 | PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement Gaia Dental Products, Inc. | EMA |
| Feb 25, 2016 | K152691 | EDS Universal Cement Essential Dental Systems, Inc. | EMA |
| Sep 10, 2015 | K151526 | Zone, ZoneFree, Zone A1 Sybron Dental Specialties | EMA |
| Aug 21, 2015 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Cl Kuraray Noritake Dental, Inc., JP | EMA |
| Aug 17, 2015 | K151332 | Nexus Universal, Nexus Universal Chroma Sybron Dental Specialties | EMA |
| Jul 22, 2015 | K150601 | Zeramic Adhesive Resin Cement Premier Dental Company Products | EMA |
| Jun 17, 2015 | K150727 | ESTECEM Tokuyama Dental Corporation, JP | EMA |
| Jun 4, 2015 | K142446 | Fixtemp Cement Exacta Dental Direct, Inc. | EMA |
| May 1, 2015 | K143212 | Bifix Temp Voco GmbH, DE | EMA |
| Feb 26, 2015 | K142623 | PANAVIA SA Cement Plus Handmix Kuraray Noritake Dental, Inc., JP | EMA |
| Jan 27, 2015 | K142625 | PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Tr Kuraray Noritake Dental, Inc., JP | EMA |
| Nov 10, 2014 | K141503 | DENALI 501CEMENT Denali Corporation | EMA |
| Oct 20, 2014 | K140993 | IONOSTAR MOLAR Voco GmbH, DE | EMA |
| Jun 10, 2014 | K134021 | ESTEMP IMPLANT, ESTEMP CLEAR Spident Co., Ltd. | EMA |
| Mar 14, 2014 | K132393 | CERCOM II CEMENT Denali Corporation | EMA |
| Oct 24, 2013 | K132255 | ULTRACEM Ultradent Products Inc. / Oratech, LLC | EMA |
| Aug 20, 2013 | K130436 | MULTILINK HYBRID ABUTMENT CEMENT Ivoclar Vivadent, AG | EMA |
| Aug 14, 2013 | K130421 | MERON APPLICATION CAPSULES Voco GmbH, DE | EMA |
| Jun 14, 2013 | K122551 | PROVITEMP Itena Clinical, CA | EMA |
| May 17, 2013 | K122974 | TRYOUT-VPS HOLDING PASTE Crown Delta Corp. | EMA |
| Apr 26, 2013 | K122549 | DENTO TEMP Itena Clinical, CA | EMA |
| Apr 19, 2013 | K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM Itena Clinical, CA | EMA |
| Mar 29, 2013 | K130223 | RMGI FILL Pulpdent Corporation | EMA |
| Feb 21, 2013 | K123824 | VITRO FIL LC Dfl Industria E Comercio SA | EMA |
| Feb 19, 2013 | K123595 | NEXUS RMGI Kerr Corporation | EMA |
| Feb 14, 2013 | K123826 | VITRO MOLAR Dfl Industria E Comercio SA | EMA |
| Jan 8, 2013 | K121621 | SOLOCEM Coltene/Whaledent AG, CH | EMA |
| Dec 7, 2012 | K123273 | HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) Temrex Corp. | EMA |
| Dec 7, 2012 | K123265 | RMGI LOW VISCOSITY Pulpdent Corporation | EMA |
| Jul 31, 2012 | K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT Novocol, Inc. | EMA |
| Jun 27, 2012 | K120243 | GAM-200 GC America, Inc. | EMA |
| Jun 18, 2012 | K120159 | BEAUTICEM SA Shofu Dental Corporation | EMA |
| Jun 8, 2012 | K120432 | TELIO CS CEM IMPLANT Ivoclar Vivadent, AG | EMA |
| Mar 30, 2012 | K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S Kuraray Medical, Inc., JP | EMA |
| Mar 30, 2012 | K120378 | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S Kuraray Medical, Inc., JP | EMA |
| Mar 28, 2012 | K112307 | RESIGLASS PASTE Shofu Dental Corporation | EMA |
| Jan 23, 2012 | K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT Prime Dental Manufacturing, Inc. | EMA |
| Dec 28, 2011 | K113040 | CERAMIR CROWN & BRIDGE Doxa Dental AB, SE | EMA |
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