Cleared Traditional

Opus Bulk Fill APS, Opus Bulk Fill Flow APS

K190758 · Dentscare Ltda · Dental

Sep 2019

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K190758 is an FDA 510(k) clearance for the Opus Bulk Fill APS, Opus Bulk Fill Flow APS, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Dentscare Ltda (Joinville, BR). The FDA issued a Cleared decision on September 4, 2019, 163 days after receiving the submission on March 25, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K190758 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2019
Decision Date	September 04, 2019
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF