OsteoPlan System— 510(k) K212570

Substantially Equivalent

Osteomed, LLC

FDA 510(k) clearance K212570 for OsteoPlan System, Substantially Equivalent on 2022-02-11. Applicant: Osteomed, LLC. Device class: 2.

Clearance details

Applicant: Osteomed, LLC
Product code: Code DZJ
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2021-08-16
Decision date: 2022-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, 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.