The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for Oral Surgery Contra.
| Device ID | K211584 |
| 510k Number | K211584 |
| Device Name: | Oral Surgery Contra |
| Classification | Handpiece, Rotary Bone Cutting |
| Applicant | Nakanishi INC. 700 Shimohinata Kanuma, JP 322-8666 |
| Contact | Masaaki Kikuchi |
| Correspondent | Yulia Nikova Ken Block Consulting LLC 800 E Campbell Road, Suite 202 Richardson, TX 75081 |
| Product Code | KMW |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2021-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264557130 | K211584 | 000 |
| 04560264557116 | K211584 | 000 |
| 04560264557109 | K211584 | 000 |