Cleared Traditional

NON-EUGENOL TEMPORARY CEMENT

K020158 · J. Morita USA, Inc. · Dental

Mar 2002

Decision

49d

Days

Class 1

Risk

About This 510(k) Submission

K020158 is an FDA 510(k) clearance for the NON-EUGENOL TEMPORARY CEMENT, 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 review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K020158 FDA.gov
FDA Decision	Cleared 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