Cleared Traditional

K080228 - ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH

K080228 is an FDA 510(k) clearance for ORALIEF OTC TOOTHPASTE 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 57-day FDA review.

K080228 · Novamin Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
57d
Days
Class 2
Risk

K080228 is an FDA 510(k) clearance for the ORALIEF OTC TOOTHPASTE 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 March 27, 2008 after a review of 57 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 Novamin Technology, Inc. devices

FDA 510(k) Submission Details - K080228

510(k) Number K080228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2008
Decision Date March 27, 2008
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 K080228.
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
VOCO PROFLUORID VARNISH
K080814 · Voco GmbH · Jul 2008
FLOR-OPAL VARNISH WHITE
K080249 · Ultradent Products, Inc. · Feb 2008
SULTAN TOOTH ROOT DESENSITIZER
K072342 · Dentsply International, Inc. · Oct 2007
CERVITEC PLUS
K072338 · Ivoclar Vivadent, Inc. · Sep 2007