K952868 is an FDA 510(k) clearance for the DENTAURUM JACKET CROWN & ROOT POSTS. This device is classified as a Pin, Retentive And Splinting, And Accessory Instruments (Class I - General Controls, product code EBL).
Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on July 19, 1995, 27 days after receiving the submission on June 22, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3740.
| 510(k) Number | K952868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1995 |
| Decision Date | July 19, 1995 |
| Days to Decision | 27 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 |