K855111 is an FDA 510(k) clearance for the DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Pacific Union Dental, Inc. (Silver Spring, US). The FDA issued a Cleared decision on March 6, 1986, 73 days after receiving the submission on December 23, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K855111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1985 |
| Decision Date | March 06, 1986 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |