Cleared Traditional

Bright Temporary C&B

K192830 · Dmp Dental Industry S.A. · Dental

Sep 2020

Decision

336d

Days

Class 2

Risk

About This 510(k) Submission

K192830 is an FDA 510(k) clearance for the Bright Temporary C&B, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Dmp Dental Industry S.A. (Markopoulo, GR). The FDA issued a Cleared decision on September 2, 2020, 336 days after receiving the submission on October 2, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K192830 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2019
Decision Date	September 02, 2020
Days to Decision	336 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement