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 |
|---|---|---|---|
| Feb 8, 1985 | K850036 | COLTENE PRECISE Coltene, Inc. | ELW |
| Dec 3, 1984 | K844329 | SURFLEX F G-C Intl. Corp. | ELW |
| Nov 9, 1984 | K842324 | PERFOURM Cutter Laboratories, Inc. | ELW |
| Oct 18, 1984 | K843145 | TWO COMPONENT RTV VINYL SILICONE MATER Crown Delta Corp. | ELW |
| Jun 27, 1984 | K841490 | POLYSULFIDE CUSTOM TRAY MATERIAL Buffalo Dental Mfg. Co., Inc. | ELW |
| Apr 6, 1983 | K830044 | ODONTIC CENTRIC(BITE) REGIST. PASTE Wallace A. Erickson & Co. | ELW |
| Feb 7, 1983 | K830083 | SHUR GEL Columbus Dental Mfg. Co. | ELW |
| Jun 7, 1982 | K821221 | DENTAL IMPRESSION MATERIAL Crown Delta Corp. | ELW |
| Mar 19, 1982 | K820489 | ULTRAFINE TRAY ADHESIVE Buffalo Dental Mfg. Co., Inc. | ELW |
| Feb 24, 1982 | K820216 | ULTRA-WET Buffalo Dental Mfg. Co., Inc. | ELW |
| Feb 24, 1982 | K820183 | SYBRON/KERR MIRROR 3 Sybron Corp. | ELW |
| Feb 22, 1982 | K820061 | REVERSIBLE HYDROCOLLOID IMPRESSION MAT Belport Co., Inc. | ELW |
| Oct 6, 1981 | K812679 | G-C FIT-CHECKER IMPRESSION MATERIAL G-C Intl. Corp. | ELW |
| Oct 6, 1981 | K812406 | EXAFLEX IMPRESSION MATERIAL G-C Intl. Corp. | ELW |
| Oct 2, 1981 | K811867 | SR-ALGICAP J. Aderer, Inc. | ELW |
| Jul 15, 1981 | K811767 | COLTENE PRESIDENT IMPRESSION MATERIALS Coltene, Inc. | ELW |
| Jul 15, 1981 | K811667 | COLTENE PRESSURE SPOT INDICATOR Coltene, Inc. | ELW |
| Jul 15, 1981 | K811666 | COLTENE COLTEX/COLTOFLAX Coltene, Inc. | ELW |
| May 5, 1981 | K811020 | REVERSIBLE HYDROCOLLOID IMPRESSION Kottler Laboratories | ELW |
| Apr 29, 1981 | K810839 | SPOTAR Moyco Industries, Inc. | ELW |
| Apr 14, 1981 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL Dental-Material Gesellschaft | ELW |
| Apr 14, 1981 | K810523 | SR-IVOSEAL J. Aderer, Inc. | ELW |
| Feb 2, 1981 | K802990 | ALGINATE/SILICONE CROWN & BRIDGE MATER Buffalo Dental Mfg. Co., Inc. | ELW |
| Jan 28, 1981 | K802882 | HYDROCOLLOID COMPATIBLE CREAM ALGINATE Buffalo Dental Mfg. Co., Inc. | ELW |
| Oct 10, 1980 | K802362 | ALGINATE IMPRESSION MATERIAL Dentsply Intl. | ELW |
| Sep 26, 1980 | K802189 | DENTLOID U.S. Shizai Corp. | ELW |
| Jul 21, 1980 | K801587 | ASH BLUEPRINT ALGINATE IMPRESSION MATER. Dentsply Intl. | ELW |
| Jul 8, 1980 | K801380 | CROWN DELTA SILICONE IMPRESSION MATERIAL Crown Delta Corp. | ELW |
| Apr 10, 1980 | K800393 | POLY SULFIDE IMPRESSION PASTE W/CATALYST American Dental Research | ELW |
| Mar 18, 1980 | K800548 | SUPERSIL Harry J. Bosworth Co. | ELW |
| Mar 18, 1980 | K800485 | VINYL POLYSILOXANE IMPRESSION MATERIAL 3M Company | ELW |
| Feb 5, 1980 | K800031 | PERMADYNE POLYETHER RUBBER IMPRESSION Espe Dental Products | ELW |
| Jan 9, 1980 | K792363 | SILAGUM Parkell, Inc. | ELW |
| Jun 15, 1979 | K790595 | DENTAL ALGINATE IMPRESSION MATERIAL Wallace A. Erickson & Co. | ELW |
| Jun 15, 1979 | K790592 | IMPRESSION MATERIAL, RUBBER Wallace A. Erickson & Co. | ELW |
| Feb 21, 1979 | K782139 | ZYLOX Premier Dental Products Co. | ELW |
| Nov 15, 1978 | K781689 | REFLECT IMPRESSION MATERIAL Kerr Corporation (Danbury) | ELW |
| Aug 31, 1978 | K781151 | REPROSIL Dentsply Intl. | ELW |
| Aug 31, 1978 | K781083 | DENTAL SILICONE IMPRESSION MATERIAL Crown Delta Corp. | ELW |
| May 31, 1978 | K780778 | RTV SILICONE HAND KNEADABLE PUTTY Crown Delta Corp. | ELW |
| Mar 15, 1978 | K780164 | RTV DENTAL SILICONE Tydont, Inc. | ELW |
| Nov 2, 1977 | K771938 | ALGINATE IMPRESSION MATERIAL The S. S. White Co. | ELW |
| Oct 13, 1977 | K771853 | PERMAGUM ADHESIVE Espe GmbH (Us) | ELW |
| Sep 2, 1977 | K771627 | PERMAGUM Espe GmbH (Us) | ELW |
| Jul 15, 1977 | K771248 | SILICONE IMPRESSION MATEOIAL Interstate Dental Co., Inc. | ELW |
| Nov 15, 1976 | K760981 | ALGINATE IMPRESSION MATERIAL Adp Intl., Inc. | ELW |
| Oct 20, 1976 | K760753 | CUTTER JEL-ALGINATE IMPRESSION MAT. Cutter Laboratories, Inc. | ELW |
| Oct 15, 1976 | K760755 | CUTTER SIL-SILICONE IMPRESSION MAT Cutter Laboratories, Inc. | ELW |
| Oct 15, 1976 | K760752 | CUTTER FLEX-SILICONE IMPRESSION MAT. Cutter Laboratories, Inc. | ELW |
| Jul 26, 1976 | K760240 | IMPRESSION MATERIAL, TRIFLEX SILICONE Oratec Dental Products | ELW |
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