Cleared Traditional

K974202 - PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS

K974202 is an FDA 510(k) clearance for PULPDENT CAVITY CLEANSER, manufactured by Pulpdent Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K974202

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.

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 107
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
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
K973919 · Medental Intl. · Dec 1997
ULTRADENT UNIVERSAL DENTIN SEALANT
K963979 · Ultradent Products, Inc. · Dec 1996