Cleared Traditional

MONOBOND PLUS

K090826 · Ivoclar Vivadent, Inc. · Dental
May 2009
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K090826 is an FDA 510(k) clearance for the MONOBOND PLUS, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on May 11, 2009, 46 days after receiving the submission on March 26, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K090826 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2009
Decision Date May 11, 2009
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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