Cleared Traditional

K131487 - FLUOR PROTECTOR S (FDA 510(k) Clearance)

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

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

Submission Details

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
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.

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
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