K820057 is an FDA 510(k) clearance for the LUXOR PORCELAIN. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Jeneric Ind. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1982, 50 days after receiving the submission on January 11, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K820057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1982 |
| Decision Date | March 02, 1982 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |