K820456 is an FDA 510(k) clearance for the CROWN & BRIDGE RESIN FOR FABRICAT/DE. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Rohm and Haas Co. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1982, 28 days after receiving the submission on February 19, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K820456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1982 |
| Decision Date | March 19, 1982 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |