Coating, Filling Material, Resin
Regulation 872.3310
1510(k)s in 12 months (52 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EBD
| Company | 510(k)s | Recalls |
|---|---|---|
| Bisco, Inc. | 6 | 0 |
| Scientific Pharmaceuticals, Inc. | 4 | 0 |
| 3M Company | 3 | 0 |
| Cosmedent, Inc. | 3 | 0 |
| Dentsply Intl. | 2 | 0 |
| GC America, Inc. | 2 | 0 |
| Kerr Dental Materials Center | 2 | 0 |
| Parkell, Inc. | 2 | 0 |
| Austenal Dental, Inc. | 1 | 0 |
| Belport Company, Inc., Gingi-Pak | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 1978 | K781345 | ULTRAFILL- ULTRABOUND Demetron Research Corp. | EBD |
| Aug 23, 1976 | K760419 | ADHESION PROMOTOR Lee Pharmaceuticals | EBD |
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