Crown And Bridge, Temporary, Resin
Regulation 872.3770
2510(k)s in 12 months (189 all time)
0recalls in 12 months (4 all time)
2recalls that name a 510(k)
Top companies in EBG
| Company | 510(k)s | Recalls |
|---|---|---|
| GC America, Inc. | 6 | 0 |
| Ivoclar Vivadent, Inc. | 6 | 0 |
| Sybron Dental Specialties, Inc. | 6 | 0 |
| Dmg USA, Inc. | 5 | 0 |
| Voco GmbH | 5 | 0 |
| 3M Company | 4 | 0 |
| Lang Dental Mfg. Co., Inc. | 2 | 2 |
| Espe GmbH (Us) | 3 | 0 |
| Ivoclar North America, Inc. | 3 | 0 |
| Kerr Dental Materials Center | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 9, 2005 | K052781 | BREFORMANCE Bredent-Products For the Dental Technician Laborat, DE | EBG |
| Dec 14, 2004 | K042820 | SYSTEMP.C&B PLUS Ivoclar Vivadent, Inc. | EBG |
| Aug 4, 2004 | K041886 | PROVISO Scientific Pharmaceuticals, Inc. | EBG |
| May 19, 2004 | K040951 | SR ADORO Ivoclar Vivadent, Inc. | EBG |
| May 13, 2004 | K041098 | COOL TEMP NATURAL Coltene AG | EBG |
| Apr 7, 2004 | K040769 | STRUCTUR 2 SC Voco GmbH | EBG |
| Jan 16, 2004 | K033227 | LUXAFORM PLUS Dmg USA, Inc. | EBG |
| Jan 15, 2004 | K033432 | LEXATITE QUICK ACRYLIC Imtec Corp. | EBG |
| Nov 21, 2003 | K033022 | PROTEMP 3 GARANT 3M Espe AG Dental Products, DE | EBG |
| Jul 2, 2003 | K031476 | FILL-IN Sybron Dental Specialties, Inc. | EBG |
| Mar 21, 2003 | K024282 | ACRYLIC Inovativ, LLC | EBG |
| Oct 30, 2002 | K023079 | NEW OUTLINE Anaxdent GmbH | EBG |
| Aug 28, 2002 | K022030 | POLY-CARB Inovativ, LLC | EBG |
| Aug 28, 2002 | K013869 | SR IVOCRON Ivoclar Vivadent, Inc. | EBG |
| Aug 1, 2002 | K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL Pentron Corp. | EBG |
| Mar 15, 2002 | K020178 | BELLEGLASS HP MODELING GEL Kerr Dental Materials Center | EBG |
| Mar 4, 2002 | K020157 | TEMPORARY CROWN AND BRIDGE MATERIAL J. Morita USA, Inc. | EBG |
| Feb 22, 2002 | K020092 | TEMPHASE Kerr Dental Materials Center | EBG |
| Feb 4, 2002 | K013895 | TEMPFIL Sybron Dental Specialties, Inc. | EBG |
| Jan 24, 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP Dmg USA, Inc. | EBG |
| Sep 6, 2001 | K012360 | LC TEMPORARY FILLING Parkell, Inc. | EBG |
| Feb 14, 2001 | K010012 | LC PROVIFILL S & C Polymer GmbH, DE | EBG |
| Jan 16, 2001 | K003817 | PATTERN RESIN GC America, Inc. | EBG |
| Dec 4, 2000 | K003377 | FERMIT N PLUS Ivoclar North America, Inc. | EBG |
| Dec 4, 2000 | K003374 | FERMIT PLUS Ivoclar North America, Inc. | EBG |
| Oct 25, 2000 | K001884 | DIRECT CROWN Flexible Dimensions, LLC | EBG |
| Aug 10, 2000 | K002364 | PROTEMP H Espe Dental AG, DE | EBG |
| Jun 13, 2000 | K001309 | HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 Kay See Dental Mfg. Co. | EBG |
| Jun 9, 2000 | K001114 | 3M QUIK TEMP TEMPORIZATION MATERIAL 3M Company | EBG |
| May 19, 2000 | K000894 | C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO Dental Ventures of America, Inc. | EBG |
| Apr 14, 2000 | K000346 | EZ CONNECT Kerr Dental Materials Center | EBG |
| Apr 5, 2000 | K000951 | LUXAFORM Dmg USA, Inc. | EBG |
| Feb 16, 2000 | K994012 | TEMPOFIT, MODEL 02693 Detax GmbH & Co. KG | EBG |
| Jun 23, 1999 | K991564 | JELTEMP J.F. Jelenko & Co., Inc. | EBG |
| May 21, 1999 | K991270 | SMARTEMP Parkell, Inc. | EBG |
| Oct 28, 1998 | K980799 | HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL Cosmedent, Inc. | EBG |
| Sep 30, 1998 | K982459 | TEMPFIL F - 2 Sybron Dental Specialties, Inc. | EBG |
| Dec 17, 1997 | K972198 | DENT-TEMP ACRYLIC Health-Dent Intl., Inc. | EBG |
| Feb 27, 1997 | K970168 | 3M QUIKPLUS SYSTEM 3M Company | EBG |
| Feb 10, 1997 | K964981 | TEMPFIL C&B Sybron Dental Specialties, Inc. | EBG |
| Feb 4, 1997 | K964691 | TCB TEMPORARY CROWN AND BRIDGE MATERIAL Scican, CA | EBG |
| Nov 19, 1996 | K963786 | TEMPFIL F Sybron Dental Specialties, Inc. | EBG |
| Jun 25, 1996 | K961199 | BOSWORTH TEMPORARY RESIN Harry J. Bosworth Co. | EBG |
| May 24, 1996 | K961198 | BOSWORTH CH I Harry J. Bosworth Co. | EBG |
| Apr 25, 1996 | K954976 | POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) Healex Products, Inc. | EBG |
| Apr 18, 1996 | K960938 | PROV-KB Silicon-Und Composite Spezialitaten GmbH, DE | EBG |
| Feb 21, 1996 | K960122 | ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL Wallace A. Erickson & Co. | EBG |
| Jan 2, 1996 | K955331 | BELLEGLASHP Sybron Dental Specialties, Inc. | EBG |
| Feb 2, 1995 | K950203 | PROTEMP(R) GARANT Espe GmbH & Co. Kg., DE | EBG |
| Dec 2, 1994 | K944981 | 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM 3M Company | EBG |
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