Cleared Traditional

BeautiBond Universal

K180803 · Shofu Dental Corporation · Dental
Sep 2018
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K180803 is an FDA 510(k) clearance for the BeautiBond Universal, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on September 26, 2018, 182 days after receiving the submission on March 28, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K180803 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2018
Decision Date September 26, 2018
Days to Decision 182 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200