K830776 is an FDA 510(k) clearance for the MICROFIL CONTOURING INSTRUMENTS. This device is classified as a Instrument, Filling, Plastic, Dental (Class I - General Controls, product code EIY).
Submitted by Almore Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983, 48 days after receiving the submission on March 11, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K830776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1983 |
| Decision Date | April 28, 1983 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIY — Instrument, Filling, Plastic, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |