Cleared Traditional

K230333 - Profisil Fluoride Varnish Combi pack (1...

K230333 is an FDA 510(k) clearance for Profisil Fluoride Varnish Combi pack (1..., manufactured by Kettenbach GmbH & Co. KG. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K230333 · Kettenbach GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
167d
Days
Class 2
Risk

K230333 is an FDA 510(k) clearance for the Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Norm.... Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on July 24, 2023 after a review of 167 days - an extended review cycle.

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. 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 Kettenbach GmbH & Co. KG devices

FDA 510(k) Submission Details - K230333

510(k) Number K230333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2023
Decision Date July 24, 2023
Days to Decision 167 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 127d · This submission: 167d
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 80
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