Cleared Traditional

K182917 - FluoroCal

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

K182917 · Bisco, Inc. · Dental device
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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

Submission Details

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.

Device Classification

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 70
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
Clinpro Varnish
K151302 · 3M Company · Sep 2015
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013