I-ENDO DUAL— 510(k) K111623

Substantially Equivalent

Satelec - Acteon Group

FDA 510(k) clearance K111623 for I-ENDO DUAL, Substantially Equivalent on 2012-01-10. Applicant: Satelec - Acteon Group. Device class: 1.

Clearance details

Applicant: Satelec - Acteon Group
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2011-06-10
Decision date: 2012-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Laurel, NJ, 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.