The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Prophy-mate.
| Device ID | K032395 |
| 510k Number | K032395 |
| Device Name: | PROPHY-MATE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NAKANISHI, INC. 700 SHIMOHINATA Kanuma-shi, Tochigi-ken, JP 322-8666 |
| Contact | Hiroji Sekiguchi |
| Correspondent | Hiroji Sekiguchi NAKANISHI, INC. 700 SHIMOHINATA Kanuma-shi, Tochigi-ken, JP 322-8666 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560224977299 | K032395 | 000 |
| 04560224977268 | K032395 | 000 |