Instrument, Hand, Calculus Removal
FDA product code ELA · Class I (low risk) · 21 CFR 872.4565 · Dental
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952363 | Opus Pacemakers (Models 4021, 4033, and 4034)ELA · Traditional | Ela Medical, Inc. | 08/15/1995SE |
| K854168 | Travenol Disposable Dental Scalers/CurettesELA · Traditional | Travenol Laboratories, S.A. | 03/13/1986SE |
| K823326 | Dental Instruments - Cutting InstrumentELA · Traditional | Miltex, Inc. | 11/24/1982SE |
| K801974 | Analytic Tech. Metal Point Heater #3001ELA · Traditional | Analytic Technology | 11/12/1980SE |