K851386 is an FDA 510(k) clearance for the UNITEK DISPOSABLE IMPRESSION SYRINGE. This device is classified as a Syringe, Restorative And Impression Material (Class I - General Controls, product code EID).
Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on April 29, 1985, 20 days after receiving the submission on April 9, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K851386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1985 |
| Decision Date | April 29, 1985 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EID — Syringe, Restorative And Impression Material |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |