Cleared Traditional

K101423 - OPTIBOND XTR

K101423 is the FDA 510(k) clearance for OPTIBOND XTR by Kerr Corporation. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K101423 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
71d
Days
Class 2
Risk

K101423 is an FDA 510(k) clearance for the OPTIBOND XTR. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on July 30, 2010 after a review of 71 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 Kerr Corporation devices

Submission Details

510(k) Number K101423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2010
Decision Date July 30, 2010
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 249
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K101423.
BEAUTIBOND MULTI PR PLUS
K110252 · Shofu Dental Corp. · May 2011
ALL-BOUND 3
K102844 · Bisco, Inc. · Oct 2010
ALL-ETCH, ALL- ETCH WITH BAC
K101485 · Bisco, Inc. · Aug 2010
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K100752 · Ultradent Products, Inc. · Jul 2010
EXCITE F AND EXCITE DSC
K093744 · Ivoclar Vivadent, Inc. · Mar 2010
PRIMER PLUS
K091705 · Bisco, Inc. · Aug 2009