Cleared Traditional

OPTIBOND ALL-IN-ONE

K060469 · Sybron Dental Specialties, Inc. · Dental
Mar 2006
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K060469 is an FDA 510(k) clearance for the OPTIBOND ALL-IN-ONE, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Sybron Dental Specialties, Inc. (Newport Beach, US). The FDA issued a Cleared decision on March 28, 2006, 33 days after receiving the submission on February 23, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K060469 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200