The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Air Torx, Model Tra-200, Tra-200-cp3, Tra-200-cp4.
| Device ID | K091065 |
| 510k Number | K091065 |
| Device Name: | AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005 |
| Contact | Keith Barritt |
| Correspondent | Keith Barritt J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-10-16 |
| Summary: | summary |