Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL

K-Number: K896915 · 1990-04-30

ApplicantJelenko Co.
Decision Date1990-04-30
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL is the device name listed in this FDA 510(k) record. The listed applicant is Jelenko Co.. It received FDA 510(k) clearance on 1990-04-30 under 510(k) number K896915. 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 PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL?

PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL is a medical device that received FDA 510(k) clearance on 1990-04-30. The listed applicant is Jelenko Co.. The 510(k) number is K896915.

When did PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL receive FDA 510(k) clearance?

PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL received FDA 510(k) clearance on 1990-04-30, under 510(k) number K896915.

Who is the listed applicant for PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL?

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 PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL?

The FDA product code for PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL is EJT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: 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.

↑