Cleared Traditional

K031444 - OPTIBOND FL

K031444 is an FDA 510(k) clearance for OPTIBOND FL, manufactured by Kerr Dental Materials Center. 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.

K031444 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
56d
Days
Class 2
Risk

K031444 is an FDA 510(k) clearance for the OPTIBOND FL. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Orange, US). The FDA issued a Cleared decision on July 2, 2003 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 Kerr Dental Materials Center devices

FDA 510(k) Submission Details - K031444

510(k) Number K031444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2003
Decision Date July 02, 2003
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 343
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K031444.
PERMAQUICK SE BONDING SYSTEM
K032626 · Ultradent Products, Inc. · Dec 2003
COMP. E
K032179 · Parkell, Inc. · Sep 2003
PULPDENT ETCH-RITE ROYALE
K031915 · Pulpdent Corporation · Aug 2003
FINAL VARNISH LC
K030844 · Voco GmbH · Jun 2003
ETCHANT 40%
K030743 · Confi-Dental Products Co. · May 2003
CLEARFIL SILANE KIT
K024356 · Kuraray Medical, Inc. · Mar 2003