The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Root Zx Ii.
| Device ID | K071190 |
| 510k Number | K071190 |
| Device Name: | ROOT ZX II |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Robert A Silverman |
| Correspondent | Robert A Silverman J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | EKX |
| Subsequent Product Code | EBZ |
| Subsequent Product Code | LQY |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548213022519 | K071190 | 000 |
| 04548213013227 | K071190 | 000 |