Cleared Traditional

BeautiLink SA

K233161 · Shofu Dental Corporation · Dental
Sep 2023
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K233161 is an FDA 510(k) clearance for the BeautiLink SA, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on September 28, 2023, 1 days after receiving the submission on September 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K233161 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date September 28, 2023
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275