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, 1976 | K760238 | IMPRESSION MATERIAL, TRIFLEX SILICONE Oratec Dental Products | ELW |
| Jul 21, 1976 | K760231 | IMPRESSION MATERIAL, DENTAL SILICON RTV Crown Delta Corp. | ELW |
| Jul 21, 1976 | K760226 | PASTE, ACCOE IMPRESSION Coe Laboratories, Inc. | ELW |
| Jul 21, 1976 | K760225 | PUTTY, ACCOE Coe Laboratories, Inc. | ELW |
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