D-LUX+— 510(k) K200809

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K200809 for D-LUX+, Substantially Equivalent on 2020-08-07. Applicant: DiaDent Group International. Device class: 2.

Clearance details

Applicant: DiaDent Group International
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2020-03-27
Decision date: 2020-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
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.