K020158 is an FDA 510(k) clearance for the NON-EUGENOL TEMPORARY CEMENT. This device is classified as a Zinc Oxide Eugenol (Class I - General Controls, product code EMB).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on March 7, 2002, 49 days after receiving the submission on January 17, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K020158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2002 |
| Decision Date | March 07, 2002 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMB — Zinc Oxide Eugenol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3275 |