K924376 is an FDA 510(k) clearance for the ROOT CANAL POST. This device is classified as a Pin, Retentive And Splinting, And Accessory Instruments (Class I - General Controls, product code EBL).
Submitted by The Thera Group (Westford, US). The FDA issued a Cleared decision on November 22, 1993, 451 days after receiving the submission on August 28, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3740.
| 510(k) Number | K924376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1992 |
| Decision Date | November 22, 1993 |
| Days to Decision | 451 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBL — Pin, Retentive And Splinting, And Accessory Instruments |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3740 |