Cleared Traditional

K092616 - ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045

K092616 is an FDA 510(k) clearance for ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, manufactured by CAO Group, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K092616 · CAO Group, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
56d
Days
Class 2
Risk

K092616 is an FDA 510(k) clearance for the ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044.... Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on October 21, 2009 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 CAO Group, Inc. devices

FDA 510(k) Submission Details - K092616

510(k) Number K092616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2009
Decision Date October 21, 2009
Days to Decision 56 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: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 372
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K092616.
OPTIBOND SE
K100347 · Kerr Corporation · Apr 2010
AMERICAN DENTAL PRODUCTS SE BONDEASY
K093014 · American Dental Products, Inc. · Apr 2010
EXCITE F AND EXCITE DSC
K093744 · Ivoclar Vivadent, Inc. · Mar 2010
PRIMER PLUS
K091705 · Bisco, Inc. · Aug 2009
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
K091300 · CAO Group, Inc. · Jul 2009
ADHESE ONE F
K090941 · Ivoclar Vivadent, Inc. · Jul 2009