K792461 is an FDA 510(k) clearance for the CENTRIX MKIV ENDODONTIC DELIVERY. This device is classified as a Syringe, Periodontic, Endodontic, Irrigating (Class I - General Controls, product code EIC).
Submitted by Centrix, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1979, 16 days after receiving the submission on December 3, 1979.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K792461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1979 |
| Decision Date | December 19, 1979 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIC — Syringe, Periodontic, Endodontic, Irrigating |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |