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 |