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 3, 2003 | K030318 | P2 POLYETHER Heraeus Kulzer, Inc. | ELW |
| Jan 22, 2003 | K023751 | EXAJET GC America, Inc. | ELW |
| Dec 18, 2002 | K024041 | ZETAPLUS SOFT Zhermack S.P.A. | ELW |
| Dec 18, 2002 | K024034 | OCCLUFAST ROCK Zhermack S.P.A. | ELW |
| Dec 13, 2002 | K023466 | TULIP ALGINATE IMPRESSION MATERIAL Cavex Holland BV, NL | ELW |
| Oct 28, 2002 | K022653 | ELITE MONOPHASE Zhermack S.P.A. | ELW |
| Oct 18, 2002 | K022430 | ISO FUNCTIONAL GC America, Inc. | ELW |
| Aug 14, 2002 | K022066 | REGISTRADO X-TRA Voco GmbH | ELW |
| May 13, 2002 | K021416 | AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL Dentsply Intl. | ELW |
| May 10, 2002 | K021413 | AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL Dentsply Intl. | ELW |
| May 8, 2002 | K021410 | AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL Dentsply Intl. | ELW |
| Apr 17, 2002 | K020242 | EMULATE FAST SET AND EMULATE REGULAR SET Cavex Holland BV, NL | ELW |
| Jan 29, 2002 | K013859 | RHODIA BITE REGISTRATION MATERIAL Rhodia, Inc. | ELW |
| Nov 1, 2001 | K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL S & C Polymer GmbH, DE | ELW |
| Nov 1, 2001 | K012517 | CEREC3 VITABLOCKS Sirona Dental Systems GmbH | ELW |
| Oct 29, 2001 | K013336 | XANTALGIN CRONO Cavex Holland BV, NL | ELW |
| Oct 22, 2001 | K013237 | STATUSBLUE Dmg USA, Inc. | ELW |
| Oct 17, 2001 | K013236 | LUXABITE Dmg USA, Inc. | ELW |
| Oct 10, 2001 | K013140 | RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL Rhodia, Inc. | ELW |
| Oct 10, 2001 | K013129 | RHODIA DENTAL PUTTY IMPRESSION MATERIAL Rhodia, Inc. | ELW |
| Sep 4, 2001 | K012405 | EXTRUDE MODIFIED Sybron Dental Specialties, Inc. | ELW |
| Sep 4, 2001 | K011785 | NOVEL PRINT CYAN ALGINATES Manufacturera Dental Continental | ELW |
| Jul 19, 2001 | K011452 | CAVEX STABISIL Cavex Holland BV, NL | ELW |
| Jul 16, 2001 | K011419 | CAVEX COLORCHANGE Cavex Holland BV, NL | ELW |
| Jun 13, 2001 | K011450 | SILICONE IMPRESSION MATERIAL Northeast Resins & Silicones, LLC | ELW |
| Apr 23, 2001 | K010994 | TAKE ONE BITE MODIFIED Kerr Corp. | ELW |
| Apr 12, 2001 | K010926 | R-SI-LINE METAL-BITE R-Dental Dentalerzeugnisse GmbH, DE | ELW |
| Mar 1, 2001 | K003808 | TAKE 1 Sybron Dental Specialties, Inc. | ELW |
| Feb 15, 2001 | K003650 | PERMLASTIC 3 Sybron Dental Specialties, Inc. | ELW |
| Feb 1, 2001 | K003930 | FLEXTIME MAGNUM 360 Heraeus Kulzer, Inc. | ELW |
| Jan 23, 2001 | K003426 | ALGINATE IMPRESSION MATERIAL Rite-Dent Manufacturing Corp. | ELW |
| Aug 10, 2000 | K001655 | PERMLASTIC 2 Kerr Corp. | ELW |
| Aug 9, 2000 | K001414 | KWIKKMODEL R-Dental Dentalerzeugnisse GmbH, DE | ELW |
| Jul 21, 2000 | K001876 | TAKE 1 BITE Sybron Dental Specialties, Inc. | ELW |
| Jul 5, 2000 | K001218 | CORRECT PLUS Jeneric/Pentron, Inc. | ELW |
| May 25, 2000 | K000686 | KROM-ALGINATE AND ALGINATE PLUS Cavex Holland BV, NL | ELW |
| Apr 13, 2000 | K994027 | ACTIVATOR PASTE Harry J. Bosworth Co. | ELW |
| Apr 11, 2000 | K000878 | HONIGUM Dmg USA, Inc. | ELW |
| Apr 5, 2000 | K000629 | FLEXTIME Heraeus Kulzer, Inc. | ELW |
| Apr 5, 2000 | K000595 | DIMENSION PENTA L Espe Dental AG, DE | ELW |
| Mar 30, 2000 | K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK Espe Dental AG, DE | ELW |
| Mar 30, 2000 | K000588 | DIMENSION GARANT L, DIMENSION GARANT L QUICK Espe Dental AG, DE | ELW |
| Feb 8, 2000 | K994172 | CEREC 3 Sirona Dental Systems GmbH | ELW |
| Jan 28, 2000 | K994193 | IMPREGUM PENTA DUOSOFT Espe Dental AG, DE | ELW |
| Jan 28, 2000 | K994192 | IMPREGUM PENTA M MONOSOFT Espe Dental AG, DE | ELW |
| Jan 27, 2000 | K994190 | IMPREGUM GARANT L DUOSOFT Espe Dental AG, DE | ELW |
| Jan 27, 2000 | K994077 | AROMA FINE (NORMAL AND FAST SET) GC America, Inc. | ELW |
| Nov 2, 1999 | K992001 | TRAY-LINK Silicon-Und Composite Spezialitaten GmbH, DE | ELW |
| Sep 8, 1999 | K992897 | IMPREGUM PENTA Espe Dental AG, DE | ELW |
| Sep 8, 1999 | K992895 | IMPREGUM F Espe Dental AG, DE | ELW |
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