The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Root Zx3.
| Device ID | K213477 |
| 510k Number | K213477 |
| Device Name: | Root ZX3 |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | J. Morita 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, Suite 1000 Washington, DC 20024 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-29 |
| Decision Date | 2022-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548213056545 | K213477 | 000 |
| 04548213056538 | K213477 | 000 |