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FDA 510(k)

PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

K-Number: K912194 · 1991-07-30

ApplicantJelenko Co.
Decision Date1991-07-30
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE is the device name listed in this FDA 510(k) record. The listed applicant is Jelenko Co.. It received FDA 510(k) clearance on 1991-07-30 under 510(k) number K912194. 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 PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE?

PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Jelenko Co.. The 510(k) number is K912194.

When did PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE receive FDA 510(k) clearance?

PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE received FDA 510(k) clearance on 1991-07-30, under 510(k) number K912194.

Who is the listed applicant for PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE?

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

What is the FDA product code for PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE?

The FDA product code for PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE is EJS.

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Other records listing Jelenko Co. 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.

K010416HERACERAM 75K003603BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HEK984164JELBOND NPK964158JEL-40 (CODE NAME RD-0430)K930762SUPERSTARK912195PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

View all 12 devices →

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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