Cleared Traditional

AlignerFlow LC

K231817 · Voco GmbH · Dental
Dec 2023
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K231817 is an FDA 510(k) clearance for the AlignerFlow LC, 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 December 1, 2023, 163 days after receiving the submission on June 21, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K231817 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2023
Decision Date December 01, 2023
Days to Decision 163 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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