Cleared Abbreviated

saremco print BRIDGETEC

K232050 · Saremco Dental AG · Dental
Nov 2023
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K232050 is an FDA 510(k) clearance for the saremco print BRIDGETEC, 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 November 14, 2023, 127 days after receiving the submission on July 10, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K232050 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2023
Decision Date November 14, 2023
Days to Decision 127 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