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FDA 510(k)

ORION WX DENTAL ALLOY

K-Number: K981002 · 1998-05-18

ApplicantEuropean Dental Imports, Inc.
Decision Date1998-05-18
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORION WX DENTAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is European Dental Imports, Inc.. It received FDA 510(k) clearance on 1998-05-18 under 510(k) number K981002. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION WX DENTAL ALLOY?

ORION WX DENTAL ALLOY is a medical device that received FDA 510(k) clearance on 1998-05-18. The listed applicant is European Dental Imports, Inc.. The 510(k) number is K981002.

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

ORION WX DENTAL ALLOY received FDA 510(k) clearance on 1998-05-18, under 510(k) number K981002.

Who is the listed applicant for ORION WX DENTAL ALLOY?

The FDA 510(k) record lists European Dental Imports, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION WX DENTAL ALLOY?

The FDA product code for ORION WX DENTAL ALLOY is EJS.

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Other records listing European Dental Imports, Inc. as applicant

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.

K982129ANTAGON PORCELAINK981001ORION VESTA DENTAL ALLOYK981000CARRARA PORCELAIN AND CARRARA VINCENT PORCELAINK980661CERA E DENTAL ALLOYK980660BIOGOLD PLUS DENTAL ALLOYK980597CARRARA PDF, CARRARA H, CARRARA R

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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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