Cleared Traditional

BZF-29

K200682 · GC America, Inc. · Dental
Oct 2020
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K200682 is an FDA 510(k) clearance for the BZF-29, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 2, 2020, 200 days after receiving the submission on March 16, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K200682 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2020
Decision Date October 02, 2020
Days to Decision 200 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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