DENJECTOR— 510(k) K081694

Substantially Equivalent

Dxm Co., Ltd.

FDA 510(k) clearance K081694 for DENJECTOR, Substantially Equivalent on 2008-09-12. Applicant: Dxm Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dxm Co., Ltd.
Product code: Code EJI
Device class: Class 2
Regulation: 21 CFR 872.6770
Advisory panel: Dental
Date received: 2008-06-17
Decision date: 2008-09-12
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.