Cleared Traditional

V-Print dentbase

K220236 · Voco GmbH · Dental
Sep 2022
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K220236 is an FDA 510(k) clearance for the V-Print dentbase, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on September 21, 2022, 237 days after receiving the submission on January 27, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K220236 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2022
Decision Date September 21, 2022
Days to Decision 237 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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