The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Adverl Evo Er: Yag Laser For Dentistry Mey-1-a.
| Device ID | K120377 |
| 510k Number | K120377 |
| Device Name: | ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548213020911 | K120377 | 000 |