Cleared Traditional

K974202 - PULPDENT CAVITY CLEANSER

K974202 is the FDA 510(k) clearance for PULPDENT CAVITY CLEANSER by Pulpdent Corp.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K974202 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
129d
Days
Class 2
Risk

K974202 is an FDA 510(k) clearance for the PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on March 19, 1998 after a review of 129 days - within the typical 510(k) review window.

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 Pulpdent Corp. devices

Submission Details

510(k) Number K974202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1997
Decision Date March 19, 1998
Days to Decision 129 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
2d slower than avg
Panel avg: 127d · This submission: 129d
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 78
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K974202.
SCI-PHARM DFV VARNISH
K982915 · Scientific Pharmaceuticals, Inc. · Feb 1999
SCI-PHARM DESENSITIZING VARNISH
K983305 · Scientific Pharmaceuticals, Inc. · Dec 1998
GREEN-OR DENTIN DESENSITIZER
K981972 · Centrix, Inc. · Dec 1998
PULPDENT CAVITY VARNISH
K974398 · Pulpdent Corp. · Feb 1998
ULTRADENT UNIVERSAL DENTIN SEALANT
K963979 · Ultradent Products, Inc. · Dec 1996
ALPHA-DENT COPAL CAVITY VARNISH
K955521 · Wallace A. Erickson & Co. · Jan 1996