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 |
|---|---|---|---|
| Jul 26, 1999 | K991631 | FASTRAY LC Harry J. Bosworth Co. | ELW |
| Jul 15, 1999 | K991490 | ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) Harry J. Bosworth Co. | ELW |
| Jul 15, 1999 | K991489 | ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) Harry J. Bosworth Co. | ELW |
| Jun 18, 1999 | K991008 | DIMENSION BITE Espe Dental AG, DE | ELW |
| Jun 15, 1999 | K991425 | XANTOPREN COMFORT Heraeus Kulzer, Inc. | ELW |
| May 20, 1999 | K991221 | VESTOGUM Espe Dental AG, DE | ELW |
| Feb 9, 1999 | K983106 | 1ST IMPRESSION Den-Mat Corp. | ELW |
| Oct 16, 1998 | K982917 | B-SYSTEM SILICONE Sybron Dental Specialties, Inc. | ELW |
| Sep 2, 1998 | K981970 | ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI Cavex Holland BV, NL | ELW |
| Jun 11, 1998 | K981325 | 3M M.G. MATERIAL 3M Company | ELW |
| Jun 9, 1998 | K980968 | LONE STAR IMPRESSION SYSTEMS Lone Star Technologies | ELW |
| May 21, 1998 | K981091 | NEOCOLLOID, ORTHOPRINT Zhermack S.P.A. | ELW |
| May 11, 1998 | K980963 | HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) Foremost Dental Mfg., Inc. | ELW |
| May 1, 1998 | K980965 | SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL Cavex Holland BV, NL | ELW |
| Feb 12, 1998 | K974894 | KROMATICA COLOR CHANGING ALGINATE Matech, Inc. | ELW |
| Jan 29, 1998 | K974704 | HYDROGUM Zhermack S.P.A. | ELW |
| Jan 29, 1998 | K974231 | POSITION PENTA, POSITION PENTA QUICK Espe GmbH & Co. Kg., DE | ELW |
| Dec 11, 1997 | K973781 | AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL Dentsply Intl. | ELW |
| Dec 4, 1997 | K973782 | AQUASIL XLV SMART WETTING IMPRESSION MATERIAL Dentsply Intl. | ELW |
| Nov 24, 1997 | K973694 | PROVIL NOVO Heraeus Kulzer, Inc. | ELW |
| Oct 21, 1997 | K973343 | HYDROFLEX GC America, Inc. | ELW |
| Oct 2, 1997 | K972871 | GENESIS Pacific Rim Dental, Inc. | ELW |
| Aug 18, 1997 | K970129 | TULIP Richard Ting | ELW |
| Aug 15, 1997 | K972276 | CEREC 2 CROWN SOFTWARE Siemens AG | ELW |
| Aug 1, 1997 | K972239 | ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING Zhermack S.P.A. | ELW |
| Jul 16, 1997 | K972027 | ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) Zhermack S.P.A. | ELW |
| May 22, 1997 | K971155 | MEMOREG Heraeus Kulzer, Inc. | ELW |
| Apr 8, 1997 | K970656 | HYDROFLEX GC America, Inc. | ELW |
| Apr 4, 1997 | K965083 | SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET S.S. White Mfg., Ltd., GB | ELW |
| Mar 31, 1997 | K970594 | KALGINATE IMPRESSION MATERIAL Teledyne Water Pik | ELW |
| Mar 27, 1997 | K970433 | AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL Dentsply Intl. | ELW |
| Mar 19, 1997 | K965165 | CUTTERSIL COMFORT HARDENER Heraeus Kulzer, Inc. | ELW |
| Mar 19, 1997 | K965163 | CUTTERSIL COMFORT Heraeus Kulzer, Inc. | ELW |
| Feb 25, 1997 | K964692 | PERFECTIM J. Morita USA, Inc. | ELW |
| Dec 30, 1996 | K964177 | KROMALGIN IMPRESSION MATERIAL North American Orthodontic Laboratories, Inc. | ELW |
| Dec 16, 1996 | K964323 | CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL Fen Dental Mfg., Inc. | ELW |
| Nov 14, 1996 | K963609 | PHASE PLUS Zhermack S.P.A. | ELW |
| Oct 31, 1996 | K963766 | 3M PROPLUS SYSTEM 3M Company | ELW |
| Oct 29, 1996 | K963205 | ALGINMAX, ORTHOCHROME American Tooth Industries | ELW |
| Sep 30, 1996 | K962680 | HYUNJAE DENTAL IMPRESSION MATERIALS Hyunjae Corp. | ELW |
| Sep 6, 1996 | K962741 | TRI-PHASIX CHROMATIC ALGINATE Parkell, Inc. | ELW |
| Aug 13, 1996 | K952614 | JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL Dentsply Intl. | ELW |
| Jun 24, 1996 | K954281 | PANASIL IMPRESSION MATERIAL Roydent Dental Products, Inc. | ELW |
| May 17, 1996 | K961201 | BOSWORTH IMPRESSION MATERIAL II Harry J. Bosworth Co. | ELW |
| Mar 15, 1996 | K960547 | DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE Espe GmbH & Co. Kg., DE | ELW |
| Mar 11, 1996 | K955932 | EXAFLEX IMPRESSION MATERIAL (MODIFICATION) GC America, Inc. | ELW |
| Mar 5, 1996 | K955892 | HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY Van R Dental Products, Inc. | ELW |
| Feb 14, 1996 | K960063 | BOSWORTH IMPRESSION MATERIAL I Harry J. Bosworth Co. | ELW |
| Dec 28, 1995 | K955465 | DEGUPRINT Degussa Corp. | ELW |
| Dec 28, 1995 | K955406 | SCAN WHITE 12 ML Vident | ELW |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.