The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Tri Auto Zx2.
| Device ID | K170275 |
| 510k Number | K170275 |
| Device Name: | Tri Auto ZX2 |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Contact | Keisuke Mori |
| Correspondent | Keith A. Barritt FISH & RICHARDSON P.C. 901 15th, St N.W SUITE 700 Washington Dc, DC 20005 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-30 |
| Decision Date | 2017-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548213055999 | K170275 | 000 |