Cleared Traditional

K060469 - OPTIBOND ALL-IN-ONE

K060469 is an FDA 510(k) clearance for OPTIBOND ALL-IN-ONE, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K060469 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
33d
Days
Class 2
Risk

K060469 is an FDA 510(k) clearance for the OPTIBOND ALL-IN-ONE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Newport Beach, US). The FDA issued a Cleared decision on March 28, 2006 after a review of 33 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.

FDA 510(k) Submission Details - K060469

510(k) Number K060469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2006
Decision Date March 28, 2006
Days to Decision 33 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 128d · This submission: 33d
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 414
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K060469.
SURPASS
K061981 · Apex Dental Materials, Inc. · Jul 2006
PORCELAIN PRIMER
K061322 · J. Morita USA, Inc. · Jun 2006
ADPER PROMPT, ADPER PROMPT L-POP
K060684 · 3M Espe AG Dental Products · Apr 2006
INTERFACE
K053103 · Apex Dental Materials, Inc. · Feb 2006
FUTURABOND NR SINGLE DOSE
K053392 · Voco GmbH · Dec 2005
VERSA-LINK PORCELAIN BONDING SYSTEM
K052699 · Sultan Chemists, Inc. · Nov 2005
K060469 · OPTIBOND ALL-IN-ONE
Download PDF FDA Summary Sybron Dental Special…