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FDA 510(k)

AUROLLOYD KF

K-Number: K983080 · 1998-10-28

ApplicantBego U.S.A.
Decision Date1998-10-28
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUROLLOYD KF is the device name listed in this FDA 510(k) record. The listed applicant is Bego U.S.A.. It received FDA 510(k) clearance on 1998-10-28 under 510(k) number K983080. 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 AUROLLOYD KF?

AUROLLOYD KF is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Bego U.S.A.. The 510(k) number is K983080.

When did AUROLLOYD KF receive FDA 510(k) clearance?

AUROLLOYD KF received FDA 510(k) clearance on 1998-10-28, under 510(k) number K983080.

Who is the listed applicant for AUROLLOYD KF?

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

What is the FDA product code for AUROLLOYD KF?

The FDA product code for AUROLLOYD KF 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 Bego U.S.A. 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.

K033279GOLD DENTAL CASTING ALLOYSK032136WIROBOND CK983082BEGOCER GK983078BEGOPALK983077BIO PONTOSTARK983079PLATINLLOYD 100

View all 7 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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