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FDA 510(k)

ORION GX ALLOY

K-Number: K032317 · 2003-09-30

ApplicantDentsply Intl.
Decision Date2003-09-30
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORION GX ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2003-09-30 under 510(k) number K032317. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION GX ALLOY?

ORION GX ALLOY is a medical device that received FDA 510(k) clearance on 2003-09-30. The listed applicant is Dentsply Intl.. The 510(k) number is K032317.

When did ORION GX ALLOY receive FDA 510(k) clearance?

ORION GX ALLOY received FDA 510(k) clearance on 2003-09-30, under 510(k) number K032317.

Who is the listed applicant for ORION GX ALLOY?

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 ORION GX ALLOY?

The FDA product code for ORION GX ALLOY is EJT.

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Related Devices (Code: EJT)

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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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