Cleared Traditional

K981972 - GREEN-OR DENTIN DESENSITIZER

K981972 is an FDA 510(k) clearance for GREEN-OR DENTIN DESENSITIZER, manufactured by Centrix, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 186-day FDA review.

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

FDA 510(k) Submission Details - K981972

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
Combination Product No
PCCP Authorized No
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.

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 108
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K981972.
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
K992629 · Centrix, Inc. · Oct 1999
SCI-PHARM DFV VARNISH
K982915 · Scientific Pharmaceuticals, Inc. · Feb 1999
SCI-PHARM DESENSITIZING VARNISH
K983305 · Scientific Pharmaceuticals, Inc. · Dec 1998
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
K974202 · Pulpdent Corp. · Mar 1998
PULPDENT CAVITY VARNISH
K974398 · Pulpdent Corp. · Feb 1998
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
K973919 · Medental Intl. · Dec 1997