Cleared Traditional

K153334 - Oral-B 5% Sodium Fluoride Varnish

K153334 is an FDA 510(k) clearance for Oral-B 5% Sodium Fluoride Varnish, manufactured by Young Dental Manufacturing Co. 1, LLC. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K153334 · Young Dental Manufacturing Co. 1, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
183d
Days
Class 2
Risk

K153334 is an FDA 510(k) clearance for the Oral-B 5% Sodium Fluoride Varnish. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on May 20, 2016 after a review of 183 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 Young Dental Manufacturing Co. 1, LLC devices

FDA 510(k) Submission Details - K153334

510(k) Number K153334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2015
Decision Date May 20, 2016
Days to Decision 183 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
55d slower than avg
Panel avg: 128d · This submission: 183d
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 118
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K153334.
FluoroCal
K182917 · Bisco, Inc. · Nov 2019
Restore Toothpaste
K181965 · Dr. Collins, Inc. · Jun 2019
V-varnish Premium
K160377 · Vericom Co., Ltd. · Dec 2016
Clinpro Varnish
K151302 · 3M Company · Sep 2015
LISTERINE Sensitivity Defense Mouthrinse
K143155 · Johnson & Johnson Healthcare Products, Division of Mcneil-Pp · Jan 2015
VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
K140350 · Preventive Technologies, Inc. · Dec 2014