Cleared Traditional

FREEPRINT crown

K222877 · Detax GmbH · Dental
Sep 2022
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K222877 is an FDA 510(k) clearance for the FREEPRINT crown, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Detax GmbH (Ettingen, DE). The FDA issued a Cleared decision on September 23, 2022, 1 days after receiving the submission on September 22, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K222877 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2022
Decision Date September 23, 2022
Days to Decision 1 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