Cleared Traditional

BracePaste Band and Build LC

K202276 · American Orthodontics · Dental
Aug 2020
Decision
3d
Days
Class 2
Risk

About This 510(k) Submission

K202276 is an FDA 510(k) clearance for the BracePaste Band and Build LC, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on August 14, 2020, 3 days after receiving the submission on August 11, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K202276 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2020
Decision Date August 14, 2020
Days to Decision 3 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DYH — Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3750

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