Cleared Traditional

K220743 - CediTEC

K220743 is the FDA 510(k) clearance for CediTEC by Voco GmbH. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

K220743 is an FDA 510(k) clearance for the CediTEC. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on July 5, 2022 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Voco GmbH devices

Submission Details

510(k) Number K220743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 140
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K220743.
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K212541 · Deltamed GmbH · Jan 2022