iBond Universal & iBond Ceramic Primer— 510(k) K150933

Name: FDA 510(k) clearance K150933
Creator: U.S. Food and Drug Administration
Published: 2015-07-07

Substantially Equivalent

Heraeus Kulzer, LLC, Mitsui Chemicals Group

FDA 510(k) clearance K150933 for iBond Universal & iBond Ceramic Primer, Substantially Equivalent on 2015-07-07. Applicant: Heraeus Kulzer, LLC, Mitsui Chemicals Group. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, LLC, Mitsui Chemicals Group
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2015-04-06
Decision date: 2015-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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