Cleared Traditional

IBOND GLUMA INSIDE

K022612 · Heraeus Kulzer, Inc. · Dental
Oct 2002
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K022612 is an FDA 510(k) clearance for the IBOND GLUMA INSIDE, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on October 28, 2002, 83 days after receiving the submission on August 6, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K022612 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2002
Decision Date October 28, 2002
Days to Decision 83 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