Cleared Traditional

K252073 - VOCO Profluorid Varnish + BioMin

K252073 is an FDA 510(k) clearance for VOCO Profluorid Varnish + BioMin, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K252073 · Voco GmbH · Dental device
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May 2026
Decision
303d
Days
Class 2
Risk

K252073 is an FDA 510(k) clearance for the VOCO Profluorid Varnish + BioMin. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on May 1, 2026 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K252073

510(k) Number K252073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2025
Decision Date May 01, 2026
Days to Decision 303 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
176d slower than avg
Panel avg: 127d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 101
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K252073.
Fluoride Varnish (Type A,Type C)
K253052 · Nagy Oral Technology Qinhuangdao Co., Ltd. · Jun 2026
UltraEZ
K261404 · Ultradent Products, Inc. · Apr 2026
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
K260830 · Sangi Co, Ltd. · Mar 2026
FluoroDose Varnish
K250714 · Centrix, Inc. · Nov 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · Theodent, LLC · May 2025
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025