Cleared Traditional

K061359 - DENSHIELD TREATMENT FOR SENSITIVE TEETH

K061359 is an FDA 510(k) clearance for DENSHIELD TREATMENT FOR SENSITIVE TEETH, manufactured by Novamin Technology, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K061359 · Novamin Technology, Inc. · Dental device
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Oct 2006
Decision
155d
Days
Class 2
Risk

K061359 is an FDA 510(k) clearance for the DENSHIELD TREATMENT FOR SENSITIVE TEETH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Novamin Technology, Inc. (Alachua, US). The FDA issued a Cleared decision on October 18, 2006 after a review of 155 days - an extended review 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: 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 Novamin Technology, Inc. devices

FDA 510(k) Submission Details - K061359

510(k) Number K061359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2006
Decision Date October 18, 2006
Days to Decision 155 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 127d · This submission: 155d
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 87
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K061359.
ULTRAEZ DESENSITIZING GEL
K061438 · Ultradent Products, Inc. · Jun 2007
ASCENT DENTAL CLEANSER
K070070 · CAO Group, Inc. · May 2007
ENAMEL PRO VARNISH
K062683 · Premier Dental Products Co. · Nov 2006
MULTIPLE (TOOTH DESENSITIZER)
K052263 · Cosmedent, Inc. · Dec 2005
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
K051750 · Ultradent Products, Inc. · Sep 2005
VIVASENS
K030922 · Ivoclar Vivadent, Inc. · Oct 2003