Cleared Traditional

Vittra APS Unique Flow

K232994 · Dentscare Ltda · Dental
Oct 2024
Decision
392d
Days
Class 2
Risk

About This 510(k) Submission

K232994 is an FDA 510(k) clearance for the Vittra APS Unique Flow, 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 18, 2024, 392 days after receiving the submission on September 22, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K232994 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2023
Decision Date October 18, 2024
Days to Decision 392 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