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)

HIGH NOBLE, TYPE III DENTAL CASTING ALLOY

K-Number: K893688 · 1989-08-23

ApplicantJelenko Co.
Decision Date1989-08-23
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIGH NOBLE, TYPE III DENTAL CASTING 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 1989-08-23 under 510(k) number K893688. 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 HIGH NOBLE, TYPE III DENTAL CASTING ALLOY?

HIGH NOBLE, TYPE III DENTAL CASTING ALLOY is a medical device that received FDA 510(k) clearance on 1989-08-23. The listed applicant is Jelenko Co.. The 510(k) number is K893688.

When did HIGH NOBLE, TYPE III DENTAL CASTING ALLOY receive FDA 510(k) clearance?

HIGH NOBLE, TYPE III DENTAL CASTING ALLOY received FDA 510(k) clearance on 1989-08-23, under 510(k) number K893688.

Who is the listed applicant for HIGH NOBLE, TYPE III DENTAL CASTING 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 HIGH NOBLE, TYPE III DENTAL CASTING ALLOY?

The FDA product code for HIGH NOBLE, TYPE III DENTAL CASTING ALLOY 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.

↑