The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Ti-max Z45.
| Device ID | K121901 |
| 510k Number | K121901 |
| Device Name: | TI-MAX Z45 |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | NAKANISHI, INC. 4-4-17 HONGO Bunkyo-ku, JP 113-0033 |
| Contact | Fumiaki Kanai |
| Correspondent | Fumiaki Kanai NAKANISHI, INC. 4-4-17 HONGO Bunkyo-ku, JP 113-0033 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2013-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264574083 | K121901 | 000 |