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FDA 510(k)

THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM

K-Number: K905197 · 1990-12-27

ApplicantOrmco Corp.
Decision Date1990-12-27
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1990-12-27 under 510(k) number K905197. 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 THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM?

THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-12-27. The listed applicant is Ormco Corp.. The 510(k) number is K905197.

When did THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM receive FDA 510(k) clearance?

THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM received FDA 510(k) clearance on 1990-12-27, under 510(k) number K905197.

Who is the listed applicant for THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM?

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

What is the FDA product code for THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM?

The FDA product code for THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM is EJT.

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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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