Biodentine XP 500, Biodentine XP 200— 510(k) K211799

Substantially Equivalent

Septodont

FDA 510(k) clearance K211799 for Biodentine XP 500, Biodentine XP 200, Substantially Equivalent on 2021-08-10. 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: 2021-06-10
Decision date: 2021-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Maur Des Fosses Cedex, FR

Download summary PDF View on FDA.gov ↗

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