Cleared Traditional

K100540 - ASCENT F-COAT MODEL: 006-00097

K100540 is an FDA 510(k) clearance for ASCENT F-COAT MODEL: 006-00097, 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 210-day FDA review.

K100540 · CAO Group, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
210d
Days
Class 2
Risk

K100540 is an FDA 510(k) clearance for the ASCENT F-COAT MODEL: 006-00097. 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 September 23, 2010 after a review of 210 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 CAO Group, Inc. devices

FDA 510(k) Submission Details - K100540

510(k) Number K100540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2010
Decision Date September 23, 2010
Days to Decision 210 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
83d slower than avg
Panel avg: 127d · This submission: 210d
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 K100540.
NUPRO MODEL 13016901
K103160 · CAO Group, Inc. · Jan 2011
MI VARNISH
K102808 · GC America, Inc. · Dec 2010
TOKUYAMA SHIELD FORCE
K100172 · Tokuyama Dental Corporation · Oct 2010
PULPDENT COPAL VARNISH WITH FLUORIDE
K100503 · Pulpdent Corporation · May 2010
PULPDENT FLUORIDE VARNISH
K093620 · Pulpdent Corporation · Mar 2010
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519 · 3M Company · Apr 2009