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 |
| 04560264566415 | K203791 | 000 |
| 04560264566408 | K203791 | 000 |
| 04589551384624 | K203791 | 000 |
| 04560264576766 | K203791 | 000 |
| 04560264570481 | K203791 | 000 |
| 04560264570474 | K203791 | 000 |
| 04560264559448 | K203791 | 000 |
| 04560264576452 | K203791 | 000 |
| 04560264576445 | K203791 | 000 |
| 04560264559363 | K203791 | 000 |
| 04560264559356 | K203791 | 000 |
| 04560264524248 | K203791 | 000 |
| 04560264513044 | K203791 | 000 |
| 04589551385744 | K203791 | 000 |
| 04560264537712 | K203791 | 000 |
| 04560264568655 | K203791 | 000 |
| 04560264568709 | K203791 | 000 |
| 04560264527249 | K203791 | 000 |
| 04560264525078 | K203791 | 000 |
| 04560264525061 | K203791 | 000 |
| 04560264525054 | K203791 | 000 |
| 04560264559349 | K203791 | 000 |
| 04560264559332 | K203791 | 000 |
| 04560264559325 | K203791 | 000 |
| 04560264559318 | K203791 | 000 |
| 04560264559301 | K203791 | 000 |
| 04560264568815 | K203791 | 000 |
| 04560264568792 | K203791 | 000 |
| 04560264568785 | K203791 | 000 |
| 04560264568754 | K203791 | 000 |
| 04560264568730 | K203791 | 000 |
| 04560264568723 | K203791 | 000 |
| 04560264535442 | K203791 | 000 |