K091065 is an FDA 510(k) clearance for the AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on October 16, 2009, 185 days after receiving the submission on April 14, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K091065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2009 |
| Decision Date | October 16, 2009 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFB — Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |