Material, Impression
Regulation 872.3660
3510(k)s in 12 months (404 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in ELW
| Company | 510(k)s | Recalls |
|---|---|---|
| Heraeus Kulzer, Inc. | 21 | 4 |
| Zhermack S.P.A. | 19 | 0 |
| Dentsply Intl. | 18 | 0 |
| Cavex Holland BV | 16 | 0 |
| GC America, Inc. | 15 | 0 |
| Harry J. Bosworth Co. | 10 | 1 |
| Sybron Dental Specialties | 10 | 1 |
| Zhermack Dental Production | 11 | 0 |
| Crown Delta Corp. | 10 | 0 |
| Espe Dental AG | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2008 | K080882 | CEREC OPTI SPRAY Sirona Dental Systems GmbH, DE | ELW |
| Mar 26, 2008 | K080514 | PECD-01 AND PECD QUICK-01 3M Espe AG Dental Products, DE | ELW |
| Mar 14, 2008 | K080130 | OCCLUFAST CAD Zhermack S.P.A. | ELW |
| Mar 10, 2008 | K073475 | SYSTEM PLUS Continental Dental Laboratory | ELW |
| Dec 12, 2007 | K073005 | ELITE GLASS Zhermack S.P.A. | ELW |
| Dec 5, 2007 | K072577 | BISICO IMPRESSION SILICONES & ALGINATES Bisico GmbH & CO KG, NL | ELW |
| Dec 4, 2007 | K072622 | STANDOUT 2 Kerr Corp. | ELW |
| Nov 8, 2007 | K072245 | EMULATE ADVANCED Cavex Holland BV, NL | ELW |
| Jun 22, 2007 | K071192 | BLUGOO HD Lancer Orthodontics, Inc. | ELW |
| May 11, 2007 | K070677 | COLORISE Zhermack S.P.A. | ELW |
| Apr 25, 2007 | K070700 | FREEALGIN Zhermack S.P.A. | ELW |
| Nov 16, 2006 | K062400 | IMPRESSIX, COLORCHANGE ALGINATE Cavex Holland BV, NL | ELW |
| Jul 17, 2006 | K060891 | VIRTUAL Ivoclar Vivadent, Inc. | ELW |
| Jul 10, 2006 | K061267 | SIMULATE, COLOR CHANGE ALGINATE Cavex Holland BV, NL | ELW |
| Jun 26, 2006 | K061427 | PRE-IMPRESSION CONDITIONING SOLUTION Dentsply Intl. | ELW |
| Mar 1, 2006 | K053619 | COLORBITE Zhermack S.P.A. | ELW |
| Jan 13, 2006 | K053427 | FRESH, DENTAL IMPRESSION MATERIAL Exacta Dental Products, Inc. | ELW |
| Jan 3, 2006 | K051933 | EXPASYL POWER APPLICATOR Sybron Dental Specialties, Inc. | ELW |
| Nov 23, 2005 | K052455 | IMPRESSIX Cavex Holland BV, NL | ELW |
| Nov 15, 2005 | K053014 | POLY SILOXANE IMPRESSION MATERIAL Clinician'S Choice Dental Products, Inc., CA | ELW |
| Nov 8, 2005 | K053018 | POLY SILOXANE IMPRESSION MATERIAL Millennium Dental International, Inc., CA | ELW |
| Oct 20, 2005 | K052409 | SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL Sultan Chemists, Inc. | ELW |
| Aug 5, 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE Discus Dental, Inc. | ELW |
| Jul 21, 2005 | K051797 | FUTURE WASH/YPS 3M Espe AG Dental Products, DE | ELW |
| Jul 19, 2005 | K050417 | ELITE IMPLANT Zhermack S.P.A. | ELW |
| Jul 15, 2005 | K051424 | HYDROGUM 5 Zhermack S.P.A. | ELW |
| Jun 28, 2005 | K051535 | MODIFICATION TO:REGISTRADO X-TRA Voco GmbH | ELW |
| Jun 23, 2005 | K051243 | JET BLUE BITE Coltene/Whaledent AG | ELW |
| Jun 21, 2005 | K051207 | CAVEX ORTHOTRACE Cavex Holland BV, NL | ELW |
| Apr 15, 2005 | K050604 | KERR VPS IMPRESSION MATERIAL Sybron Dental Specialties, Inc. | ELW |
| Mar 4, 2005 | K043493 | FUSION PUTTY TYPE GC America, Inc. | ELW |
| Feb 18, 2005 | K043054 | GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL Sultan Chemists, Inc. | ELW |
| Feb 9, 2005 | K050013 | RETRACTOFOAM Coltene/Whaledent AG | ELW |
| Jan 27, 2005 | K043471 | FUSION FAST GC America, Inc. | ELW |
| Jan 24, 2005 | K043118 | HYDROGUM SOFT Zhermack S.P.A. | ELW |
| Dec 17, 2004 | K042878 | FLEXITIME XTREME Heraeus Kulzer, Inc. | ELW |
| Dec 15, 2004 | K043131 | TORPICALGIN Zhermack S.P.A. | ELW |
| Dec 3, 2004 | K042860 | CORRECT DENTAL IMPRESSION MATERIAL Handae Chemical Co., Ltd., KR | ELW |
| Jun 25, 2004 | K041398 | GC FUSION GC America, Inc. | ELW |
| Jun 17, 2004 | K041229 | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) Cosmedent, Inc. | ELW |
| May 14, 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL Crown Delta Corp. | ELW |
| Mar 25, 2004 | K040053 | PRECISION VPS IMPRESSION MATERIAL Discus Dental, Inc. | ELW |
| Nov 20, 2003 | K032708 | PLASTALGIN AND PLASTALGIN ORTHO Septodont | ELW |
| Oct 20, 2003 | K032289 | FIT CHECKER II GC America, Inc. | ELW |
| Oct 2, 2003 | K031439 | ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) Harry J. Bosworth Co. | ELW |
| Sep 30, 2003 | K032116 | TULIP COLORSWITCH Cavex Holland BV, NL | ELW |
| Aug 11, 2003 | K032001 | POLY Q (GARANT L, PENTA M, PENTA H) 3M Espe AG Dental Products, DE | ELW |
| Jul 3, 2003 | K031484 | STAND OUT Kerr Corp. | ELW |
| May 9, 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL Discus Dental, Inc. | ELW |
| Apr 9, 2003 | K030414 | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL Sultan Chemists, Inc. | ELW |
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