K905640 is an FDA 510(k) clearance for the SOLID CORE GUTTA PERCHA CARRIER. This device is classified as a File, Pulp Canal, Endodontic (Class I - General Controls, product code EKS).
Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on March 5, 1991, 78 days after receiving the submission on December 17, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K905640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1990 |
| Decision Date | March 05, 1991 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKS — File, Pulp Canal, Endodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |