K933582 is an FDA 510(k) clearance for the PROFILE SERIES 29 FILES. This device is classified as a File, Pulp Canal, Endodontic (Class I - General Controls, product code EKS).
Submitted by Tulsa Dental Products, Ltd. (Tulsa, US). The FDA issued a Cleared decision on October 20, 1993, 89 days after receiving the submission on July 23, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K933582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1993 |
| Decision Date | October 20, 1993 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EKS — File, Pulp Canal, Endodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |