K962031 is an FDA 510(k) clearance for the QUANTEC SERIES 2000 ENDODONTIC FILES. This device is classified as a File, Pulp Canal, Endodontic (Class I - General Controls, product code EKS).
Submitted by Tycom Dental (Irvine, US). The FDA issued a Cleared decision on June 4, 1996, 11 days after receiving the submission on May 24, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K962031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1996 |
| Decision Date | June 04, 1996 |
| Days to Decision | 11 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 |