Cleared Traditional

FLUOR PROTECTOR (K946032) - FDA 510(k) Clearance

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

K946032 · Ivoclar North America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
88d
Days
Class 2
Risk

K946032 is an FDA 510(k) clearance for the FLUOR PROTECTOR. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K946032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date March 07, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
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 28
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K946032.
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · Dentsply Intl. · Aug 2002
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822 · Dentsply Intl. · Nov 1999
ACA THYROXINE ANALYTICAL TEST PACK
K833701 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984
CAVITY VARNISH
K810913 · Dentsply Intl. · Sep 1981