K213477 is an FDA 510(k) clearance for the Root ZX3. This device is classified as a Unit, Electrosurgical, And Accessories, Dental (Class II - Special Controls, product code EKZ).
Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on August 3, 2022, 278 days after receiving the submission on October 29, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4920.
| 510(k) Number | K213477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2021 |
| Decision Date | August 03, 2022 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKZ — Unit, Electrosurgical, And Accessories, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4920 |