BIODENTINE— 510(k) K140132

Substantially Equivalent

Septodont

FDA 510(k) clearance K140132 for BIODENTINE, Substantially Equivalent on 2014-06-27. Applicant: Septodont. Device class: 2.

Clearance details

Applicant: Septodont
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2014-01-17
Decision date: 2014-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, 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.