Cleared Traditional

Llis, Vittra APS

K191306 · Dentscare Ltda · Dental
Dec 2019
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K191306 is an FDA 510(k) clearance for the Llis, Vittra 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 December 16, 2019, 216 days after receiving the submission on May 14, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K191306 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2019
Decision Date December 16, 2019
Days to Decision 216 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