Cleared Traditional

BrackFix

K183147 · Voco GmbH · Dental
Mar 2019
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K183147 is an FDA 510(k) clearance for the BrackFix, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on March 1, 2019, 108 days after receiving the submission on November 13, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K183147 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2018
Decision Date March 01, 2019
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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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