Cleared Traditional

ADHESE ONE F

K090941 · Ivoclar Vivadent, Inc. · Dental
Jul 2009
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K090941 is an FDA 510(k) clearance for the ADHESE ONE F, 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 July 17, 2009, 105 days after receiving the submission on April 3, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K090941 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2009
Decision Date July 17, 2009
Days to Decision 105 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