The following data is part of a premarket notification filed by J. Mortia Usa, Inc. with the FDA for Lubrina 2.
| Device ID | K190509 |
| 510k Number | K190509 |
| Device Name: | Lubrina 2 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | J. Mortia USA, Inc. 9 Mason Irvine, CA 92618 |
| Contact | Fujio Zushi |
| Correspondent | Keith A. Barritt Fish & Richardson P.C. 1000 Maine Ave. S.W. 9th Floor Washington, DC 20024 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-01 |
| Decision Date | 2020-03-04 |