Cleared Traditional

K923546 - OPTIBOND

K923546 is an FDA 510(k) clearance for OPTIBOND, manufactured by Kerr Corporation (Danbury). The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K923546 · Kerr Corporation (Danbury) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
75d
Days
Class 2
Risk

K923546 is an FDA 510(k) clearance for the OPTIBOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kerr Corporation (Danbury) (Romulus, US). The FDA issued a Cleared decision on September 29, 1992 after a review of 75 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 (Danbury) devices

FDA 510(k) Submission Details - K923546

510(k) Number K923546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1992
Decision Date September 29, 1992
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
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 380
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K923546.
RESTOBOND 4
K924378 · Lee Pharmaceuticals · Mar 1993
CLEARFIL PORCELAIN BOND ACTIVATOR
K925404 · Kuraray Co. · Jan 1993
POLIBOND
K924181 · Voco GmbH · Oct 1992
BISCO UNIVERSAL BOND-3
K923842 · Bisco, Inc. · Sep 1992
COLTENE A.R.T. BOND
K922615 · Coltene/Whaledent, Inc. · Aug 1992
DURAFILL BOND
K921701 · Heraeus Kulzer, Inc. · Jun 1992