Cleared Traditional

K953167 - ULTRACID DISINFECTING SOLOUTION

K953167 is the FDA 510(k) clearance for ULTRACID DISINFECTING SOLOUTION by Ultradent Products, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K953167 · Ultradent Products, Inc. · Dental device
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Sep 1995
Decision
63d
Days
Class 2
Risk

K953167 is an FDA 510(k) clearance for the ULTRACID DISINFECTING SOLOUTION. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 63 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K953167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1995
Decision Date September 08, 1995
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 70
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K953167.
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
ULTRACID F DISINFECTING SOLUTION
K953168 · Ultradent Products, Inc. · Sep 1995
FLUOR PROTECTOR
K946032 · Ivoclar North America, Inc. · Mar 1995
BOSWORTH COPALIONER
K933505 · Harry J. Bosworth Co. · Jan 1994