Charisma— 510(k) K160049

Name: FDA 510(k) clearance K160049
Creator: U.S. Food and Drug Administration
Published: 2016-11-15

Substantially Equivalent

Heraeus Kulzer, LLC (Mitsui Chemicals Group)

FDA 510(k) clearance K160049 for Charisma, Substantially Equivalent on 2016-11-15. Applicant: Heraeus Kulzer, LLC (Mitsui Chemicals Group). Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, LLC (Mitsui Chemicals Group)
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2016-01-11
Decision date: 2016-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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