The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for Stainless Turbine.
| Device ID | K203791 |
| 510k Number | K203791 |
| Device Name: | Stainless Turbine |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NAKANISHI INC. 700 Shimohinata Kanuma, JP 322-8666 |
| Contact | Masaaki Kikuchi |
| Correspondent | Kelby Villarreal Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson, TX 75081 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2022-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264527263 | K203791 | 000 |
| 04560264566408 | K203791 | 000 |
| 04589551384624 | K203791 | 000 |
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| 00810021437835 | K203791 | 000 |