Star-X, Intraoral X-ray System— 510(k) K190357

Substantially Equivalent

Hdx Will Corp.

FDA 510(k) clearance K190357 for Star-X, Intraoral X-ray System, Substantially Equivalent on 2019-03-15. Applicant: Hdx Will Corp.. Device class: 2.

Clearance details

Applicant: Hdx Will Corp.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2019-02-15
Decision date: 2019-03-15
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.