IBOND TOTAL ETCH— 510(k) K083652

Substantially Equivalent

Heraeus Kulzer,GmbH

FDA 510(k) clearance K083652 for IBOND TOTAL ETCH, Substantially Equivalent on 2009-01-21. Applicant: Heraeus Kulzer,GmbH. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer,GmbH
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2008-12-09
Decision date: 2009-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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K050854 — PALACOS LV+G2005-07-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.