Cleared Traditional

HKBOND 2006

K063062 · Heraeus Kulzer, Inc. · Dental
Dec 2006
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K063062 is an FDA 510(k) clearance for the HKBOND 2006, 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 December 1, 2006, 57 days after receiving the submission on October 5, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K063062 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2006
Decision Date December 01, 2006
Days to Decision 57 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