Cleared Traditional

Vittra APS Unique

K210231 · Dentscare Ltda · Dental
Oct 2021
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K210231 is an FDA 510(k) clearance for the Vittra APS Unique, 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 October 14, 2021, 259 days after receiving the submission on January 28, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K210231 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2021
Decision Date October 14, 2021
Days to Decision 259 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