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FDA 510(k)

ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM

K-Number: K964659 · 1996-12-23

ApplicantDentsply Intl.
Decision Date1996-12-23
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1996-12-23 under 510(k) number K964659. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM?

ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is Dentsply Intl.. The 510(k) number is K964659.

When did ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM receive FDA 510(k) clearance?

ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM received FDA 510(k) clearance on 1996-12-23, under 510(k) number K964659.

Who is the listed applicant for ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM?

The FDA product code for ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM is EHD.

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Related Devices (Code: EHD)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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