K875351 is an FDA 510(k) clearance for the DEN-MAT PORETCH (PORCELAIN ETCHANT). This device is classified as a Teeth, Porcelain (Class II - Special Controls, product code ELL).
Submitted by Den-Mat Corp. (Santa Maria, US). The FDA issued a Cleared decision on March 18, 1988, 78 days after receiving the submission on December 31, 1987.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.
| 510(k) Number | K875351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 1987 |
| Decision Date | March 18, 1988 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELL — Teeth, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3920 |