Diafil & Diafil Capsule— 510(k) K210421

Name: FDA 510(k) clearance K210421
Creator: U.S. Food and Drug Administration
Published: 2021-06-28

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K210421 for Diafil & Diafil Capsule, Substantially Equivalent on 2021-06-28. Applicant: DiaDent Group International. Device class: 2.

Clearance details

Applicant: DiaDent Group International
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2021-02-11
Decision date: 2021-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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