LUXEN 5G— 510(k) K241151

Substantially Equivalent

Dentalmax Co., Ltd.

FDA 510(k) clearance K241151 for LUXEN 5G, Substantially Equivalent on 2024-09-30. Applicant: Dentalmax Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dentalmax Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2024-04-25
Decision date: 2024-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheonan-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.