Cement, Dental
Regulation 872.3275
10510(k)s in 12 months (509 all time)
0recalls in 12 months (16 all time)
13recalls that name a 510(k)
Top companies in EMA
| Company | 510(k)s | Recalls |
|---|---|---|
| GC America, Inc. | 30 | 0 |
| Voco GmbH | 26 | 2 |
| Shofu Dental Corp. | 24 | 0 |
| Dentsply Intl. | 19 | 0 |
| Pulpdent Corp. | 14 | 0 |
| Sybron Dental Specialties | 14 | 0 |
| 3M Company | 12 | 0 |
| Bisco, Inc. | 9 | 2 |
| Espe GmbH (Us) | 10 | 0 |
| Coltene/Whaledent AG | 9 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 4, 1978 | K771114 | NEUTROCIM Septodont, Inc. | EMA |
| Aug 19, 1977 | K771481 | TONGUE BLADE HOLDER Welch Allyn, Inc. | EMA |
| Aug 16, 1977 | K771451 | SCUTABOND Premier Dental Products Co. | EMA |
| Jun 1, 1977 | K770923 | ESPETEMP (TEMP. CEMENT) Espe GmbH (Us) | EMA |
| Jan 25, 1977 | K770067 | CYANOBOND Parker Laboratories, Inc. | EMA |
| Jan 3, 1977 | K761355 | SELFAST Septodont, Inc. | EMA |
| Jan 3, 1977 | K761354 | CIMPAT (PINK AND WHITE) Septodont, Inc. | EMA |
| Nov 15, 1976 | K760978 | ZINC CEMENT Adp Intl., Inc. | EMA |
| Jul 26, 1976 | K760239 | CEMENT, ULTRA-BOND Oratec Dental Products | EMA |
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