HYPERION— 510(k) K113497

Substantially Equivalent

Cefla S.C. Cefla Dental Group

FDA 510(k) clearance K113497 for HYPERION, Substantially Equivalent on 2012-01-17. Applicant: Cefla S.C. Cefla Dental Group. Device class: 2.

Clearance details

Applicant: Cefla S.C. Cefla Dental Group
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2011-11-25
Decision date: 2012-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola, IT

Download summary PDF View on FDA.gov ↗

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