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 |
|---|---|---|---|
| Aug 15, 2014 | K140966 | VONFLEX S BITE Vericom Co., Ltd., KR | ELW |
| Jun 19, 2014 | K132869 | SILDENT Hrs Co., Ltd., KR | ELW |
| Jun 5, 2014 | K140602 | FLASH PENTA MB QUICK, FLASH MB QUICK 3M Espe AG, DE | ELW |
| May 28, 2014 | K133071 | ELASTIC IMPRESSION MATERIAL Rizhao Huge Dental Industry Co., Ltd. | ELW |
| May 21, 2014 | K140074 | HYGEDENT ALGINATE IMPRESSION MATERIAL Hygedent, Inc., CN | ELW |
| Apr 9, 2014 | K134008 | MD-FLEX HEAVY BODY Meta Biomed, Inc. | ELW |
| Mar 7, 2014 | K133527 | SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT Osstem Germany GmbH | ELW |
| Mar 7, 2014 | K133436 | FLASH AR; FLASH AR QUICK 3M Deutschland GmbH, DE | ELW |
| Mar 6, 2014 | K133400 | FLASH BITE 3M Espe AG, DE | ELW |
| Feb 25, 2014 | K132599 | SMILEBOND SYSTEM Millennium Company, LLC | ELW |
| Dec 20, 2013 | K131510 | POLYDIMETHYLSILOXANE IMPRESSION MATERIAL Blackwell Device Consulting | ELW |
| Jul 2, 2013 | K130920 | CORRECT PLUS 1 Pentron Clinical | ELW |
| May 30, 2013 | K131404 | FLASH AR PENTA / FLASH AR PENTA QUICK 3M Deutschland GmbH, DE | ELW |
| May 30, 2013 | K130869 | TAKE 1 ADVANCE Sybron Dental Specialties | ELW |
| May 17, 2013 | K130647 | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML Heraeus Kulzer, LLC | ELW |
| Aug 23, 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 Lascod Spa | ELW |
| Jul 25, 2012 | K120914 | FLEXITIME FAST & SCAN LIGHT FLOW Heraeus Kulzer, LLC | ELW |
| Jul 13, 2012 | K113574 | FLEXITIME MONOPHASE PRO SCAN Heraeus Kulzer, LLC | ELW |
| May 22, 2012 | K120013 | TEMPSPAN CLEAR MATRIX Pentron Clinical | ELW |
| May 10, 2012 | K120521 | GC BLUE SILICONE GC America, Inc. | ELW |
| May 2, 2012 | K120438 | FLASH (DIFFERENT MATERIALS) 3M Deutschland GmbH, DE | ELW |
| Feb 13, 2012 | K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL Dentsply International, Inc. | ELW |
| Nov 14, 2011 | K113279 | IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT Kettenbach GmbH & Co. KG, DE | ELW |
| Nov 14, 2011 | K113263 | ARGES IMAGING CONTRAST SPRAY Arges Imaging, Inc. | ELW |
| Jun 17, 2011 | K110871 | FIT CHECKER ADVANCED GC America, Inc. | ELW |
| Apr 8, 2011 | K110092 | TAKE 1 ADVANCED RIGID TRAY Kerr Corporation | ELW |
| Apr 5, 2011 | K110378 | IMPRESSION COMPOUND Spofadental | ELW |
| Mar 30, 2011 | K103586 | IOS FASTSCAN SPRAY Ios Technnologies, Inc. | ELW |
| Mar 28, 2011 | K110050 | FIT TEST C&B Voco GmbH, DE | ELW |
| Feb 11, 2011 | K103346 | DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY Sherpa Korea | ELW |
| Jan 13, 2011 | K102836 | BONASIL A+ IMPRESSION MATERIALS Dmp, Ltd., GR | ELW |
| Dec 21, 2010 | K102770 | FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW Heraeus Kulzer, LLC | ELW |
| Dec 8, 2010 | K102739 | HYDROCOLOR 5 Cascades Device Consulting Associates | ELW |
| Nov 10, 2010 | K103164 | VONFLEX HEAVY, VINFLEX LIGHT Vericom Co., Ltd., KR | ELW |
| Sep 7, 2010 | K101617 | FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL Heraeus Kulzer, LLC | ELW |
| Jan 28, 2010 | K092176 | TAKE 1 ADVANCED RIGID TRAY Kerr Corporation | ELW |
| Oct 7, 2009 | K091613 | TAKE 1 Kerr Corp. | ELW |
| Oct 1, 2009 | K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT Kettenbach GmbH & Co. KG, DE | ELW |
| Sep 16, 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 Danville Materials, Inc. | ELW |
| Jul 31, 2009 | K091494 | FLEXITIME FLOW Heraeus Kulzer, Inc. | ELW |
| May 6, 2009 | K091267 | VONFLEX PUTTY Vericom Co., Ltd., KR | ELW |
| Mar 26, 2009 | K083739 | HYDRORISE AND HYDROSYSTEM Zhermack S.P.A. | ELW |
| Jan 9, 2009 | K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY Kettenbach GmbH & Co. KG | ELW |
| Dec 5, 2008 | K082591 | FLEXITIME BITE Heraeus Kulzer, Inc., Dental Products Division | ELW |
| Sep 8, 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT Kettenbach GmbH & Co. KG, DE | ELW |
| Aug 6, 2008 | K082157 | KETTOSIL AND SILGINAT Kettenbach GmbH & Co. KG, DE | ELW |
| Aug 4, 2008 | K081017 | TEMPLATE AND COUNTER-FIT Clinician'S Choice Dental Products, Inc., CA | ELW |
| May 14, 2008 | K081084 | COLORISE RIGID Zhermack S.P.A. | ELW |
| May 1, 2008 | K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS Kettenbach GmbH & Co. KG, DE | ELW |
| Apr 21, 2008 | K080338 | CUTTERSIL ACTIVATOR UNIVERSAL PLUS Heraeus Kulzer,GmbH | ELW |
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