Cleared Traditional

Allcem Veneer APS

K191389 · Dentscare Ltda · Dental
Feb 2020
Decision
277d
Days
Class 2
Risk

About This 510(k) Submission

K191389 is an FDA 510(k) clearance for the Allcem Veneer 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 February 25, 2020, 277 days after receiving the submission on May 24, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K191389 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2019
Decision Date February 25, 2020
Days to Decision 277 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690