K020157 is an FDA 510(k) clearance for the TEMPORARY CROWN AND BRIDGE MATERIAL. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on March 4, 2002, 46 days after receiving the submission on January 17, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K020157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2002 |
| Decision Date | March 04, 2002 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |