Cleared Traditional

K973919 - CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)

K973919 is an FDA 510(k) clearance for CAVITY VARNISH (INTERMEDIARY VARNISH AN..., manufactured by Medental Intl.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K973919 · Medental Intl. · Dental device
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Dec 1997
Decision
62d
Days
Class 2
Risk

K973919 is an FDA 510(k) clearance for the CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL). Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Medental Intl. (Evergreen, US). The FDA issued a Cleared decision on December 16, 1997 after a review of 62 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 Medental Intl. devices

FDA 510(k) Submission Details - K973919

510(k) Number K973919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1997
Decision Date December 16, 1997
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
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 85
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K973919.
GREEN-OR DENTIN DESENSITIZER
K981972 · Centrix, Inc. · Dec 1998
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
K974202 · Pulpdent Corp. · Mar 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
ULTRACID DISINFECTING SOLOUTION
K953167 · Ultradent Products, Inc. · Sep 1995