Instruments, Dental Hand
Regulation 872.4565
0510(k)s in 12 months (16 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in DZN
| Company | 510(k)s | Recalls |
|---|---|---|
| Den-Mat Corp. | 2 | 0 |
| Howmedica Corp. | 2 | 0 |
| Accor, Inc. | 1 | 0 |
| Alvin Meyer, D.D.S. | 1 | 0 |
| Centrix, Inc. | 1 | 0 |
| Dentsply Intl. | 1 | 0 |
| Fly Cast Technologies, Inc. | 1 | 0 |
| Healthco, Inc. | 1 | 0 |
| Ivoclar North America, Inc. | 1 | 0 |
| Kerrhawe SA | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2015 | Ultradent Products, Inc. InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012
Product Usage:
InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent Terminated |
DZN | None listed |
| Nov 5, 2012 | Ormco/Sybronendo Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. Terminated |
DZN | None listed |
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