The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Ti-max X450.
| Device ID | K112024 |
| 510k Number | K112024 |
| Device Name: | TI-MAX X450 |
| 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 | 2011-07-15 |
| Decision Date | 2012-06-20 |
| Summary: | summary |