Cleared Traditional

Opallis, Opallis Flow

K201707 · Dentscare Ltda · Dental
Dec 2020
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K201707 is an FDA 510(k) clearance for the Opallis, Opallis 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 December 22, 2020, 183 days after receiving the submission on June 22, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K201707 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2020
Decision Date December 22, 2020
Days to Decision 183 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