K970339 is an FDA 510(k) clearance for the TRI AUTO ZX. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on June 4, 1997, 126 days after receiving the submission on January 29, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K970339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1997 |
| Decision Date | June 04, 1997 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EKX — Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |