Cleared Traditional

K262243 - Profisil Free

K262243 is an FDA 510(k) clearance for Profisil Free, 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 64-day FDA review.

K262243 · Kettenbach GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
64d
Days
Class 2
Risk

K262243 is an FDA 510(k) clearance for the Profisil Free. 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 September 3, 2026 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kettenbach GmbH & Co. KG devices

FDA 510(k) Submission Details - K262243

510(k) Number K262243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2026
Decision Date September 03, 2026
Days to Decision 64 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
64d faster than avg
Panel avg: 128d · This submission: 64d
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 119
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K262243.
Fluoride Varnish (Type A,Type C)
K253052 · Nagy Oral Technology Qinhuangdao Co., Ltd. · Jun 2026
VOCO Profluorid Varnish + BioMin
K252073 · Voco GmbH · May 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