Cleared Traditional

K120109 - SUPER SEAL TOOTH DESENSITIZER

K120109 is the FDA 510(k) clearance for SUPER SEAL TOOTH DESENSITIZER by Phoenix Dental, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K120109 · Phoenix Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
54d
Days
Class 2
Risk

K120109 is an FDA 510(k) clearance for the SUPER SEAL TOOTH DESENSITIZER. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Phoenix Dental, Inc. (Fenton, US). The FDA issued a Cleared decision on March 7, 2012 after a review of 54 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 Phoenix Dental, Inc. devices

Submission Details

510(k) Number K120109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2012
Decision Date March 07, 2012
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 127d · This submission: 54d
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 61
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K120109.
Restore Toothpaste
K181965 · Dr. Collins, Inc. · Jun 2019
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SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013
MI VARNISH
K102808 · GC America, Inc. · Dec 2010
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519 · 3M Company · Apr 2009
VOCO PROFLUORID L
K083036 · Voco GmbH · Jan 2009