Cleared Traditional

BracePaste MTP Light Cure Primer

K181910 · American Orthodontics · Dental
Oct 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K181910 is an FDA 510(k) clearance for the BracePaste MTP Light Cure Primer, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on October 15, 2018, 90 days after receiving the submission on July 17, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K181910 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2018
Decision Date October 15, 2018
Days to Decision 90 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