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FDA 510(k)

GDC-1136 CASTING ALLOY FOR PORCELAIN-FU

K-Number: K813200 · 1981-12-31

ApplicantNey
Decision Date1981-12-31
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GDC-1136 CASTING ALLOY FOR PORCELAIN-FU is the device name listed in this FDA 510(k) record. The listed applicant is Ney. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813200. 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 GDC-1136 CASTING ALLOY FOR PORCELAIN-FU?

GDC-1136 CASTING ALLOY FOR PORCELAIN-FU is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Ney. The 510(k) number is K813200.

When did GDC-1136 CASTING ALLOY FOR PORCELAIN-FU receive FDA 510(k) clearance?

GDC-1136 CASTING ALLOY FOR PORCELAIN-FU received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813200.

Who is the listed applicant for GDC-1136 CASTING ALLOY FOR PORCELAIN-FU?

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

What is the FDA product code for GDC-1136 CASTING ALLOY FOR PORCELAIN-FU?

The FDA product code for GDC-1136 CASTING ALLOY FOR PORCELAIN-FU is EJS.

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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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