Cleared Traditional

Franz Zirconia Dental Crown

K203072 · Franz Biotech, Inc. · Dental

Jan 2022

Decision

467d

Days

Class 2

Risk

About This 510(k) Submission

K203072 is an FDA 510(k) clearance for the Franz Zirconia Dental Crown, a Teeth, Porcelain (Class II — Special Controls, product code ELL), submitted by Franz Biotech, Inc. (Taipei City, TW). The FDA issued a Cleared decision on January 19, 2022, 467 days after receiving the submission on October 9, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3920.

Submission Details

510(k) Number	K203072 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2020
Decision Date	January 19, 2022
Days to Decision	467 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF