Cleared Traditional

K051006 - IBOND NEXT GENERATION
(FDA 510(k) Clearance)

K051006 · Heraeus Kulzer,GmbH · Dental
Jun 2005
Decision
48d
Days
Class 2
Risk

K051006 is an FDA 510(k) clearance for the IBOND NEXT GENERATION, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on June 7, 2005, 48 days after receiving the submission on April 20, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K051006 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2005
Decision Date June 07, 2005
Days to Decision 48 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