Cleared Traditional

FiteBac CC OrthoSeal

K210115 · Largent Health, LLC · Dental
Jul 2021
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K210115 is an FDA 510(k) clearance for the FiteBac CC OrthoSeal, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Largent Health, LLC (Marietta, US). The FDA issued a Cleared decision on July 29, 2021, 191 days after receiving the submission on January 19, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K210115 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2021
Decision Date July 29, 2021
Days to Decision 191 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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