Cleared Traditional

K122331 - CAVITY VARNISH

K122331 is an FDA 510(k) clearance for CAVITY VARNISH, manufactured by Dentsply International, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K122331 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
74d
Days
Class 2
Risk

K122331 is an FDA 510(k) clearance for the CAVITY VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on October 15, 2012 after a review of 74 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 Dentsply International, Inc. devices

FDA 510(k) Submission Details - K122331

510(k) Number K122331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2012
Decision Date October 15, 2012
Days to Decision 74 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
53d faster than avg
Panel avg: 127d · This submission: 74d
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 100
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K122331.
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013
PRG BARRIER COAT
K122908 · Shofu Dental Corporation · Apr 2013
REMESENSE FOR SENSITIVE TEETH
K122708 · Sylphar N.V. · Jan 2013
SENZZZZZ AWAY
K120176 · Centrix, Inc. · Jul 2012
SUPER SEAL TOOTH DESENSITIZER
K120109 · Phoenix Dental, Inc. · Mar 2012
PCXX VARNISH
K113146 · Ross Healthcare, Inc. · Jan 2012