Cleared Traditional

K220236 - V-Print dentbase

K220236 is the FDA 510(k) clearance for V-Print dentbase by Voco GmbH. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

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

K220236 is an FDA 510(k) clearance for the V-Print dentbase. 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 September 21, 2022 after a review of 237 days - an extended review cycle.

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 K220236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 127d · This submission: 237d
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 K220236.
Denture Base Resin
K230115 · Aidite (Qinhuangdao) Technology Co., Ltd. · Mar 2023
Dentca Base Premium, Dentca Base Hi-Impact
K220042 · Dentca, Inc. · Nov 2022
SprintRay High Impact Denture Base
K221678 · Sprintray, Inc. · Nov 2022
SprintRay Denture Base
K220979 · Sprintray, Inc. · Sep 2022
Denture Base Polymers
K220680 · Shandong Huge Dental Material Corporation · Aug 2022
TERA HARZ DENTURE
K222414 · Graphy, Inc. · Aug 2022