K121901 is an FDA 510(k) clearance for the TI-MAX Z45. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Nakanishi, Inc. (Bunkyo-Ku, JP). The FDA issued a Cleared decision on February 28, 2013, 244 days after receiving the submission on June 29, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K121901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2012 |
| Decision Date | February 28, 2013 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EGS — Handpiece, Contra- And Right-angle Attachment, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |