Cleared Traditional

K050486 - PROTECT TOOTH DESENSITIZER

K050486 is an FDA 510(k) clearance for PROTECT TOOTH DESENSITIZER, manufactured by Sunstar Butler. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K050486 · Sunstar Butler · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
102d
Days
Class 2
Risk

K050486 is an FDA 510(k) clearance for the PROTECT TOOTH DESENSITIZER. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Sunstar Butler (Chicago, US). The FDA issued a Cleared decision on June 7, 2005 after a review of 102 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K050486

510(k) Number K050486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2005
Decision Date June 07, 2005
Days to Decision 102 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
26d faster than avg
Panel avg: 128d · This submission: 102d
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 138
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K050486.
DENSHIELD TREATMENT FOR SENSITIVE TEETH
K061359 · Novamin Technology, Inc. · Oct 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
ORALIEF THERAPY FOR SENSITIVE TEETH
K040858 · Novamin Technology, Inc. · Sep 2004
ORAVIVE TOOTH REVITALIZING PASTE
K040473 · Novamin Technology, Inc. · Mar 2004
VARNISHAMERICA
K040098 · Medical Products Laboratories, Inc. · Feb 2004
K050486 · PROTECT TOOTH DESENSITIZER
Download PDF FDA Summary Sunstar Butler