Cleared Abbreviated

Saremco Print CROWNTEC

K213343 · Saremco Dental AG · Dental
Jan 2022
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K213343 is an FDA 510(k) clearance for the Saremco Print CROWNTEC, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Saremco Dental AG (Rebstein, CH). The FDA issued a Cleared decision on January 21, 2022, 106 days after receiving the submission on October 7, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K213343 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2021
Decision Date January 21, 2022
Days to Decision 106 days
Submission Type Abbreviated
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