K062856 is an FDA 510(k) clearance for the TF ROTARY NICKEL TITANIUM FILE. This device is classified as a File, Pulp Canal, Endodontic (Class I - General Controls, product code EKS).
Submitted by Ormco Corp. (Newport Beach, US). The FDA issued a Cleared decision on December 13, 2006, 79 days after receiving the submission on September 25, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K062856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2006 |
| Decision Date | December 13, 2006 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKS — File, Pulp Canal, Endodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |