Cleared Traditional

OptiBond eXTRa Universal

K182162 · Kerr Corporation · Dental
Nov 2018
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K182162 is an FDA 510(k) clearance for the OptiBond eXTRa Universal, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on November 7, 2018, 89 days after receiving the submission on August 10, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K182162 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2018
Decision Date November 07, 2018
Days to Decision 89 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