Point, Abrasive
FDA product code EHL · Class I (low risk) · 21 CFR 872.6010 · Dental
4510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K792250 | Cutter PointsEHL · Traditional | Cutter Laboratories, Inc. | 01/23/1980SE |
| K780811 | Dental Abrasive DeviceEHL · Traditional | Cavitron Corp. | 06/22/1978SE |
| K780377 | Pinidentoflex Dental PolisherEHL · Traditional | Cavitron Corp. | 03/14/1978SE |
| K780376 | Minidentoflex New Polishing SystemEHL · Traditional | Cavitron Corp. | 03/14/1978SE |