ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM— 510(k) K964659

Name: FDA 510(k) clearance K964659
Creator: U.S. Food and Drug Administration
Published: 1996-12-23

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K964659 for ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM, Substantially Equivalent on 1996-12-23. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 1996-11-20
Decision date: 1996-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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