Cleared Traditional

BracePaste Fluoride Sealant

K242537 · American Orthodontics Corp. · Dental

Aug 2024

Decision

Days

Class 2

Risk

About This 510(k) Submission

K242537 is an FDA 510(k) clearance for the BracePaste Fluoride Sealant, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by American Orthodontics Corp. (Sheboygan, US). The FDA issued a Cleared decision on August 27, 2024, 1 days after receiving the submission on August 26, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number	K242537 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2024
Decision Date	August 27, 2024
Days to Decision	1 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF