K112665 is an FDA 510(k) clearance for the TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on May 4, 2012, 234 days after receiving the submission on September 13, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K112665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2011 |
| Decision Date | May 04, 2012 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKX — Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |