Dia-X Bond Universal— 510(k) K220804

Name: FDA 510(k) clearance K220804
Creator: U.S. Food and Drug Administration
Published: 2022-06-15

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K220804 for Dia-X Bond Universal, Substantially Equivalent on 2022-06-15. Applicant: DiaDent Group International. Device class: 2.

Clearance details

Applicant: DiaDent Group International
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2022-03-18
Decision date: 2022-06-15
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.