The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Tri Auto Zx.
| Device ID | K970339 |
| 510k Number | K970339 |
| Device Name: | TRI AUTO ZX |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Contact | Terry G Mahn |
| Correspondent | Terry G Mahn J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-29 |
| Decision Date | 1997-06-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TRI AUTO ZX 79274481 not registered Live/Pending |
J. MORITA MFG. CORP. 2019-10-31 |