POINT 500 HD POINT500C HD— 510(k) K121800

Substantially Equivalent

Pointnix Co., Ltd.

FDA 510(k) clearance K121800 for POINT 500 HD POINT500C HD, Substantially Equivalent on 2013-01-24. Applicant: Pointnix Co., Ltd.. Device class: 2.

Clearance details

Applicant: Pointnix Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2012-06-19
Decision date: 2013-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.