Cleared Traditional

GREEN-OR DENTIN DESENSITIZER (K981972) - FDA 510(k) Clearance

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

K981972 · Centrix, Inc. · Dental device
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Dec 1998
Decision
186d
Days
Class 2
Risk

K981972 is an FDA 510(k) clearance for the GREEN-OR DENTIN DESENSITIZER. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on December 7, 1998 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Centrix, Inc. devices

Submission Details

510(k) Number K981972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1998
Decision Date December 07, 1998
Days to Decision 186 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
59d slower than avg
Panel avg: 127d · This submission: 186d
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 K981972.
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