Cleared Traditional

K070070 - ASCENT DENTAL CLEANSER

K070070 is an FDA 510(k) clearance for ASCENT DENTAL CLEANSER, manufactured by CAO Group, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K070070 · CAO Group, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
137d
Days
Class 2
Risk

K070070 is an FDA 510(k) clearance for the ASCENT DENTAL CLEANSER. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 137 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.

View all CAO Group, Inc. devices

FDA 510(k) Submission Details - K070070

510(k) Number K070070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2007
Decision Date May 25, 2007
Days to Decision 137 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
10d slower than avg
Panel avg: 127d · This submission: 137d
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 101
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K070070.
SULTAN TOOTH ROOT DESENSITIZER
K072342 · Dentsply International, Inc. · Oct 2007
CERVITEC PLUS
K072338 · Ivoclar Vivadent, Inc. · Sep 2007
ULTRAEZ DESENSITIZING GEL
K061438 · Ultradent Products, Inc. · Jun 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