Cleared Traditional

K182917 - FluoroCal

K182917 is an FDA 510(k) clearance for FluoroCal, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K182917 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
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Nov 2019
Decision
395d
Days
Class 2
Risk

K182917 is an FDA 510(k) clearance for the FluoroCal. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on November 18, 2019 after a review of 395 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 Bisco, Inc. devices

FDA 510(k) Submission Details - K182917

510(k) Number K182917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2018
Decision Date November 18, 2019
Days to Decision 395 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
268d slower than avg
Panel avg: 127d · This submission: 395d
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 K182917.
DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
K192381 · Scientific Pharmaceuticals · Feb 2020
Cervitec F
K191453 · Ivoclar Vivadent, AG · Feb 2020
FiteBac Cavity Cleanser
K190271 · Largent Health, LLC · Jan 2020
Restore Toothpaste
K181965 · Dr. Collins, Inc. · Jun 2019
V-varnish Premium
K160377 · Vericom Co., Ltd. · Dec 2016
Oral-B 5% Sodium Fluoride Varnish
K153334 · Young Dental Manufacturing Co. 1, LLC · May 2016