K993526 is an FDA 510(k) clearance for the SYNEA - LS LOW-SPEED HANDPIECE. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on January 11, 2000, 85 days after receiving the submission on October 18, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K993526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1999 |
| Decision Date | January 11, 2000 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EFB — Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |