Tray, Impression, Preformed
Regulation 872.6880
0510(k)s in 12 months (16 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in EHY
| Company | 510(k)s | Recalls |
|---|---|---|
| Buffalo Dental Mfg. Co., Inc. | 2 | 0 |
| Di-Equi Dental Products | 2 | 0 |
| J. Aderer, Inc. | 2 | 0 |
| Advantage Dental Co. | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Dentsply Intl. | 1 | 0 |
| Harry J Bosworth Company | 0 | 1 |
| Implant Direct Sybron Manufacturing, LLC | 0 | 1 |
| Ivoclar North America, Inc. | 1 | 0 |
| Kerr Corporation (Danbury) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 1994 | K942668 | O-TRAY IMPRESSION TRAYS Dentauraum, Inc. | EHY |
| Feb 9, 1990 | K896470 | EOS IMPRESSION TRAYS Ivoclar North America, Inc. | EHY |
| Dec 22, 1988 | K884316 | OCCLUSAL HARMONY IMPRESSION TRAY Advantage Dental Co. | EHY |
| Oct 14, 1986 | K863836 | POST TRAY Market Masters, Inc. | EHY |
| Mar 18, 1985 | K850776 | PREFORMED DENTAL IMPRESSION TRAYS L.A.K. Ent., Inc. | EHY |
| Jul 31, 1984 | K842274 | F-G-P TRAY Di-Equi Dental Products | EHY |
| Jul 31, 1984 | K842273 | CROWN INDEX TRAY Di-Equi Dental Products | EHY |
| Jul 13, 1984 | K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS Buffalo Dental Mfg. Co., Inc. | EHY |
| Jun 27, 1984 | K841323 | FUZZY TRAY Buffalo Dental Mfg. Co., Inc. | EHY |
| Dec 26, 1983 | K833485 | IMPRESSION TUBE ADJUSTABLE Zefr, Inc. | EHY |
| Mar 17, 1981 | K810525 | SR-IVOTRAY UNIVERSAL J. Aderer, Inc. | EHY |
| Mar 17, 1981 | K810524 | SR-IVOTRAY SPECIAL J. Aderer, Inc. | EHY |
| Jul 21, 1980 | K801548 | PERF-LOCK IMPRESSION TRAY Dentsply Intl. | EHY |
| Apr 29, 1980 | K800900 | PREMIER TRIPLE TRAY Premier Dental Products Co. | EHY |
| Apr 28, 1978 | K780678 | IMPRESSION TRAY Rocky Mountain Orthodontics, Inc. | EHY |
| Feb 16, 1978 | K780211 | 4-IN-1 DISP. CROWN & BRIDGE TRAY Kerr Corporation (Danbury) | EHY |
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