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FDA 510(k)

ORION E ALLOY

K-Number: K032316 · 2003-09-30

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

Device Summary

ORION E 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 K032316. 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 E ALLOY?

ORION E 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 K032316.

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

ORION E ALLOY received FDA 510(k) clearance on 2003-09-30, under 510(k) number K032316.

Who is the listed applicant for ORION E 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 E ALLOY?

The FDA product code for ORION E ALLOY is EJT.

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Related Devices (Code: EJT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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