Cleared Traditional

BeautiBond Xtreme

K213965 · Shofu Dental Corporation · Dental
Mar 2022
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K213965 is an FDA 510(k) clearance for the BeautiBond Xtreme, 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 March 18, 2022, 88 days after receiving the submission on December 20, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K213965 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2021
Decision Date March 18, 2022
Days to Decision 88 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