The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Tri Auto Mini - Endodeontic Treatment Motorized Handpiece.
| Device ID | K112665 |
| 510k Number | K112665 |
| Device Name: | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, 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 | 2011-09-13 |
| Decision Date | 2012-05-04 |
| Summary: | summary |