Cleared Traditional

K093014 - AMERICAN DENTAL PRODUCTS SE BONDEASY

K093014 is an FDA 510(k) clearance for AMERICAN DENTAL PRODUCTS SE BONDEASY, manufactured by American Dental Products, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K093014 · American Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
199d
Days
Class 2
Risk

K093014 is an FDA 510(k) clearance for the AMERICAN DENTAL PRODUCTS SE BONDEASY. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by American Dental Products, Inc. (Bensenville, US). The FDA issued a Cleared decision on April 16, 2010 after a review of 199 days - an extended review 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: 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 American Dental Products, Inc. devices

FDA 510(k) Submission Details - K093014

510(k) Number K093014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date April 16, 2010
Days to Decision 199 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
72d slower than avg
Panel avg: 127d · This submission: 199d
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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K093014.
OPTIBOND XTR
K101423 · Kerr Corporation · Jul 2010
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K100752 · Ultradent Products, Inc. · Jul 2010
OPTIBOND SE
K100347 · Kerr Corporation · Apr 2010
EXCITE F AND EXCITE DSC
K093744 · Ivoclar Vivadent, Inc. · Mar 2010
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045
K092616 · CAO Group, Inc. · Oct 2009
PRIMER PLUS
K091705 · Bisco, Inc. · Aug 2009