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 |
|---|---|---|---|
| Dec 1, 1995 | K954192 | IMPREGUM PENTA Espe GmbH & Co. Kg., DE | ELW |
| Nov 21, 1995 | K954180 | MICROGLISS Espe GmbH & Co. Kg., DE | ELW |
| Nov 15, 1995 | K954662 | THERMALASTIC/TRIPOLYVINALENE Tak Systems | ELW |
| Oct 17, 1995 | K935892 | INDURENT GEL Zhermack Dental Production | ELW |
| Sep 29, 1995 | K954223 | AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING American Dental Products, Inc. | ELW |
| Sep 29, 1995 | K952728 | RETRAC Centrix, Inc. | ELW |
| Sep 8, 1995 | K952930 | DENTRAY II PLUS TRAY ADHESIVE Confi-Dental Products Co. | ELW |
| Sep 8, 1995 | K935890 | ZETAPLUS (PUTTY) Zhermack Dental Production | ELW |
| Aug 29, 1995 | K952422 | ELASTIC IMPRESSION CREAM Teledyne Water Pik | ELW |
| Aug 22, 1995 | K935898 | HYDROGUM Zhermack Dental Production | ELW |
| Aug 18, 1995 | K953374 | PERMADYNE GARANT 2:1 Espe GmbH & Co. Kg., DE | ELW |
| Aug 18, 1995 | K952693 | RAMITEC PENTA Espe GmbH & Co. Kg., DE | ELW |
| Jul 19, 1995 | K953027 | PERMADYNE PENTA (HIGH & LOW VISCOSITY) Espe GmbH & Co. Kg., DE | ELW |
| May 23, 1995 | K950299 | CEREC 2 Pelton & Crane Co. | ELW |
| Apr 10, 1995 | K951237 | ALGI-BAND Health-Dent Intl., Inc. | ELW |
| Mar 31, 1995 | K951075 | S & C VINYL POLYSILOXANE IMPRESSION MATERIAL S & C Polymer GmbH, DE | ELW |
| Jan 11, 1995 | K945142 | POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) Scican, CA | ELW |
| Sep 12, 1994 | K943388 | GC SURFLEX F GC America, Inc. | ELW |
| Sep 9, 1994 | K935896 | THIXOFLEX Zhermack Dental Production, IT | ELW |
| Aug 23, 1994 | K943574 | CAPTURE IMPRESSION MATERIAL Dentsply Intl. | ELW |
| Aug 23, 1994 | K935889 | OCCLUFAST Zhermack Dental Production, IT | ELW |
| Aug 23, 1994 | K935888 | ELITE FAST LIGHT BODY Zhermack Dental Production, IT | ELW |
| Aug 23, 1994 | K935887 | ELITE REGULAR BODY Zhermack Dental Production, IT | ELW |
| Aug 23, 1994 | K935886 | ELITE LIGHT BODY Zhermack Dental Production, IT | ELW |
| Aug 23, 1994 | K935885 | ELITE FAST PUTTY SOFT Zhermack Dental Production, IT | ELW |
| Aug 23, 1994 | K935884 | ELITE PUTTY SOFT Zhermack Dental Production, IT | ELW |
| Aug 23, 1994 | K931242 | ELITE PUTTY HARD Zhermack Dental Production, IT | ELW |
| Aug 12, 1994 | K943475 | ULTRA HYDROPHILIC ALGINAE Essential Dental Systems, Inc. | ELW |
| Aug 12, 1994 | K942219 | ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS Robert W. Bauer & Assoc., Inc. | ELW |
| Aug 10, 1994 | K942666 | ORTHALGENAT IMPRESSION MATERIAL Dentauraum, Inc. | ELW |
| May 27, 1994 | K940860 | CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS Ultradent Products, Inc. | ELW |
| Apr 28, 1994 | K940685 | PRETREATMENT SOLUTION Dentsply Intl. | ELW |
| Apr 4, 1994 | K935151 | HYDROCOLLOID HEATING UNIT Centrix, Inc. | ELW |
| Mar 28, 1994 | K940402 | SUPERGEL/SUPPRESSED DUST Harry J. Bosworth Co. | ELW |
| Mar 22, 1994 | K940379 | EXTRUDE Sybron Dental Specialties, Inc. | ELW |
| Feb 25, 1994 | K940120 | ALPHA-DENT Wallace A. Erickson & Co. | ELW |
| Feb 4, 1994 | K936070 | TREND SET 2 PLUS Confi-Dental Products Co. | ELW |
| Jan 21, 1994 | K925746 | REPLICA Matech, Inc. | ELW |
| Jan 7, 1994 | K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM Crown Delta Corp. | ELW |
| Sep 29, 1993 | K933206 | EXA BITE REGISTRATION MATERIAL GC America, Inc. | ELW |
| Sep 10, 1993 | K921571 | 1ST IMPRESSION Wykle Research, Inc. | ELW |
| Aug 9, 1993 | K932459 | FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL 3M Company | ELW |
| May 5, 1993 | K926033 | VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD Harry J. Bosworth Co. | ELW |
| Mar 18, 1993 | K925370 | TRIANGULAR JAW MICROLARYNGEAL FORCEPS Pilling Co. | ELW |
| Aug 27, 1992 | K923202 | Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL Jeneric/Pentron, Inc. | ELW |
| Apr 28, 1992 | K914178 | CORRECTED-V.P.S. Jeneric/Pentron, Inc. | ELW |
| Jan 17, 1992 | K914437 | CORRECT-S.I.M. Jeneric/Pentron, Inc. | ELW |
| Jan 17, 1992 | K895901 | VITA CEREC SET AND VITA CEREC BLOCS Vident | ELW |
| Jan 9, 1992 | K912001 | CONVERTRAY, MODIFICATION Wilde Dental (Usa) | ELW |
| Nov 13, 1991 | K913583 | CONVERSIL FL AND CONVERSIL P Wilde-USA, Inc. | ELW |
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