LUXEN Zr, LUXEN Smile— 510(k) K171585

Substantially Equivalent

Dentalmax Co., Ltd.

FDA 510(k) clearance K171585 for LUXEN Zr, LUXEN Smile, Substantially Equivalent on 2018-10-31. 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: 2017-05-31
Decision date: 2018-10-31
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.