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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 128d · 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 131
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K080228.
DURASHIELD PLUS
K082198 · Dentsply Intl., Inc. · Oct 2008
ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT
K082071 · Adpharma, Inc. · Oct 2008
VOCO PROFLUORID VARNISH
K080814 · Voco GmbH · Jul 2008
THE PROXIVENT KIT
K073061 · Coll Partners , Ltd. · Feb 2008
FLOR-OPAL VARNISH WHITE
K080249 · Ultradent Products, Inc. · Feb 2008
DENTIN DESENSITIZER AGENT
K073117 · Dentsply Intl., Inc. · Dec 2007
K080228 · ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
Download PDF FDA Summary Novamin Technology, I…