The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for Fx Contra.
| Device ID | K222518 |
| 510k Number | K222518 |
| Device Name: | FX Contra |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| 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 | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-19 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04589551383986 | K222518 | 000 |
| 04560264578494 | K222518 | 000 |
| 04560264578470 | K222518 | 000 |
| 04560264578456 | K222518 | 000 |
| 04560264575196 | K222518 | 000 |
| 04589551387175 | K222518 | 000 |