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 |
|---|---|---|---|
| Oct 4, 1991 | K913537 | MEMOSIL C.D. Heraeus Kulzer, Inc. | ELW |
| Jul 25, 1991 | K912485 | COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC Coltene/Whaledent, Inc. | ELW |
| Jun 6, 1991 | K910360 | CUTTERSIL FUNCTION ACTIVATOR Heraeus Kulzer, Inc. | ELW |
| Jun 6, 1991 | K910189 | PERFOURM PUTTY SOFT Heraeus Kulzer, Inc. | ELW |
| Jun 6, 1991 | K910166 | CUTTERSIL XL Heraeus Kulzer, Inc. | ELW |
| Jun 6, 1991 | K910165 | CUTTERSIL MUCOSA Heraeus Kulzer, Inc. | ELW |
| Mar 15, 1991 | K905032 | MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL Parkell | ELW |
| Dec 28, 1990 | K904927 | HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM Hennson Intl., Inc. | ELW |
| Nov 29, 1990 | K904482 | STAT.BR TM Kerr Corporation (Danbury) | ELW |
| Oct 19, 1990 | K903292 | ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS Coe Laboratories, Inc. | ELW |
| Sep 7, 1990 | K901866 | DEGUFLEX (R) CS LIGHT Degussa AG, DE | ELW |
| Sep 6, 1990 | K901867 | DEGUFLEX (R) CS PUTTY Degussa AG, DE | ELW |
| Sep 6, 1990 | K901865 | DEGUFLEX MONOPHASE Degussa AG, DE | ELW |
| Jun 15, 1990 | K901681 | FORMASIL(R)A POLYVINYL SILOXANE LINE Kulzer, Inc. | ELW |
| Apr 30, 1990 | K896468 | EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL Ivoclar North America, Inc. | ELW |
| Apr 19, 1990 | K896786 | ZONAREX FINAL IMPRESSION COMPOUND Craft Dental Laboratory, Inc. | ELW |
| Apr 19, 1990 | K896785 | ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ Craft Dental Laboratory, Inc. | ELW |
| Feb 9, 1990 | K896539 | PERMADYNE GARANT LOW VISCOSITY Espe GmbH (Us) | ELW |
| Dec 22, 1989 | K894282 | FIRST IMPRESSION TM Coe Laboratories, Inc. | ELW |
| Dec 4, 1989 | K892412 | POLYETHER-RETARDER Espe GmbH (Us) | ELW |
| Oct 27, 1989 | K892839 | PALGARAPID Espe GmbH (Us) | ELW |
| Sep 26, 1989 | K894281 | FIRST IMPRESSION WITH CHLORHEXIDINE Coe Laboratories, Inc. | ELW |
| Jul 27, 1989 | K890449 | PERMAGUM PUTTY SOFT & PERMAGUM GARRANT Wacker-Chemie GmbH, MY | ELW |
| Jul 14, 1989 | K892935 | RESOUND IMPRESSION MATERIAL Resound Corp. | ELW |
| Apr 17, 1989 | K884166 | DICOR CERAMIC INLAY - NEW TECHNIC Dentsply Intl. | ELW |
| Mar 17, 1989 | K883842 | DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. Dentsply Intl. | ELW |
| Jan 4, 1989 | K884381 | PALGAFLEX AND PALGAFLEX-QUICK Espe GmbH (Us) | ELW |
| Sep 23, 1988 | K882800 | COLTENE PRESIDENT JET REGULAR BODY Coltene, Inc. | ELW |
| Aug 11, 1988 | K882690 | IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL 3M Company | ELW |
| Jun 28, 1988 | K881091 | OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL Coe Laboratories, Inc. | ELW |
| Jul 21, 1987 | K872745 | VINYL POLYSILOXANE IMPRESSION SYSTEM Crown Delta Corp. | ELW |
| Jun 11, 1987 | K871409 | VINYL POLYSILOXANE IMPRESSION SYSTEM Crown Delta Corp. | ELW |
| Mar 19, 1987 | K870011 | CONTRASYL IMPRESSION MATERIAL Contracap | ELW |
| Jan 29, 1987 | K870047 | COLTENE RAPID Coltene, Inc. | ELW |
| Dec 1, 1986 | K863288 | HYDROPHILIC REPROSIL Dentsply Intl. | ELW |
| Sep 25, 1986 | K862879 | NEW LIGHT-CURING IMPRESSION MATERIAL Dentsply Intl. | ELW |
| Jun 16, 1986 | K860855 | SHUR GEL 4 Columbus Dental Mfg. Co. | ELW |
| Apr 21, 1986 | K853089 | SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE Psp Dental Co., Ltd., GB | ELW |
| Mar 26, 1986 | K860911 | AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL Austenal Dental, Inc. | ELW |
| Mar 20, 1986 | K860532 | KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL Kerr Corporation (Danbury) | ELW |
| Mar 17, 1986 | K860146 | POLYJEL N.F. (NEW FORMULA) Dentsply Intl. | ELW |
| Mar 17, 1986 | K854106 | BAYSILEX Cutter Laboratories, Inc. | ELW |
| Mar 17, 1986 | K853529 | IMPREGUM-F Espe GmbH (Us) | ELW |
| Mar 6, 1986 | K855112 | DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS Pacific Union Dental, Inc. | ELW |
| Mar 6, 1986 | K855111 | DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES Pacific Union Dental, Inc. | ELW |
| Jan 30, 1986 | K854855 | PROOF ALGINATE IMPRESSION MATERIAL Sybron Corp. | ELW |
| Oct 29, 1985 | K844446 | BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. Pulpdent Corp. of America | ELW |
| May 29, 1985 | K851388 | SEPTOSIL SILICONE FOR PRECISION IMPRESSION Specialites Septodont | ELW |
| May 1, 1985 | K851469 | 76 ELW BITE CHECKER SILICONE G-C Intl. Corp. | ELW |
| Mar 11, 1985 | K842877 | ABSOLUTE VINYL POLYSILOXANE IMPRESS Coe Laboratories, Inc. | ELW |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.