Cleared Traditional

ADHESE ONE

K070646 · Ivoclar Vivadent, Inc. · Dental
May 2007
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K070646 is an FDA 510(k) clearance for the ADHESE ONE, 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, 2007, 64 days after receiving the submission on March 8, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K070646 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2007
Decision Date May 11, 2007
Days to Decision 64 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