Cleared Traditional

K131487 - FLUOR PROTECTOR S

K131487 is an FDA 510(k) clearance for FLUOR PROTECTOR S, manufactured by Ivoclar Vivadent, AG. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 503-day FDA review.

K131487 · Ivoclar Vivadent, AG · Dental device
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Oct 2014
Decision
503d
Days
Class 2
Risk

K131487 is an FDA 510(k) clearance for the FLUOR PROTECTOR S. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on October 8, 2014 after a review of 503 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Ivoclar Vivadent, AG devices

FDA 510(k) Submission Details - K131487

510(k) Number K131487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2013
Decision Date October 08, 2014
Days to Decision 503 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
376d slower than avg
Panel avg: 127d · This submission: 503d
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 K131487.
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STARBRIGHT 5% SODIUM FLUORIDE VARNISH
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COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
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