Cleared Traditional

K182917 - FluoroCal (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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
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 136
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K182917.
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
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025