Cleared Traditional

Monobond Etch & Prime

K150164 · Ivoclar Vivadent, AG · Dental
Apr 2015
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K150164 is an FDA 510(k) clearance for the Monobond Etch & Prime, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on April 3, 2015, 67 days after receiving the submission on January 26, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K150164 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2015
Decision Date April 03, 2015
Days to Decision 67 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