K082716 is an FDA 510(k) clearance for the A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43. 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 15, 2009, 120 days after receiving the submission on September 17, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K082716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2008 |
| Decision Date | January 15, 2009 |
| Days to Decision | 120 days |
| Submission Type | Abbreviated |
| 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 |