The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Lubrina, Model Him-1.
| Device ID | K070074 |
| 510k Number | K070074 |
| Device Name: | LUBRINA, MODEL HIM-1 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 1425 K ST. N.W. 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 | 2007-01-08 |
| Decision Date | 2007-05-31 |
| Summary: | summary |