The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Prophy-mate Neo.
| Device ID | K112673 |
| 510k Number | K112673 |
| Device Name: | PROPHY-MATE NEO |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-14 |
| Decision Date | 2012-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264572492 | K112673 | 000 |
| 04560264572478 | K112673 | 000 |
| 04560264572461 | K112673 | 000 |
| 04560264572454 | K112673 | 000 |
| 04589551383283 | K112673 | 000 |
| 04560264574953 | K112673 | 000 |
| 04589551382774 | K112673 | 000 |
| 04560264507166 | K112673 | 000 |