K832654 is an FDA 510(k) clearance for the HEATED GUTTA PERCHA DELIVERY SYSTEM. This device is classified as a Gutta-percha (Class I - General Controls, product code EKM).
Submitted by Unitek Corp. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983, 49 days after receiving the submission on August 8, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3850.
| 510(k) Number | K832654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1983 |
| Decision Date | September 26, 1983 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKM — Gutta-percha |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3850 |