Cleared Traditional

CediTEC

K220743 · Voco GmbH · Dental
Jul 2022
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K220743 is an FDA 510(k) clearance for the CediTEC, 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 July 5, 2022, 113 days after receiving the submission on March 14, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K220743 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2022
Decision Date July 05, 2022
Days to Decision 113 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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