Cleared Traditional

ADHESE UNIVERSAL

K133318 · Ivoclar Vivadent, AG · Dental
Feb 2014
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K133318 is an FDA 510(k) clearance for the ADHESE UNIVERSAL, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on February 11, 2014, 106 days after receiving the submission on October 28, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K133318 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2013
Decision Date February 11, 2014
Days to Decision 106 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