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FDA 510(k)

GOLD/PALLADIUM BASED DENTAL ALLOY

K-Number: K885302 · 1989-02-13

ApplicantJelenko Co.
Decision Date1989-02-13
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GOLD/PALLADIUM BASED DENTAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Jelenko Co.. It received FDA 510(k) clearance on 1989-02-13 under 510(k) number K885302. 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 GOLD/PALLADIUM BASED DENTAL ALLOY?

GOLD/PALLADIUM BASED DENTAL ALLOY is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Jelenko Co.. The 510(k) number is K885302.

When did GOLD/PALLADIUM BASED DENTAL ALLOY receive FDA 510(k) clearance?

GOLD/PALLADIUM BASED DENTAL ALLOY received FDA 510(k) clearance on 1989-02-13, under 510(k) number K885302.

Who is the listed applicant for GOLD/PALLADIUM BASED DENTAL ALLOY?

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 GOLD/PALLADIUM BASED DENTAL ALLOY?

The FDA product code for GOLD/PALLADIUM BASED DENTAL ALLOY is EJT.

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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)K930762SUPERSTARK912194PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

View all 12 devices →

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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