K233117 is an FDA 510(k) clearance for the Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT). This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on June 20, 2024, 267 days after receiving the submission on September 27, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K233117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | June 20, 2024 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBW — Controller, Foot, Handpiece And Cord |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |