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FDA 510(k)

ORTHOTECH DURA-GOLD BARCKETS

K-Number: K933080 · 1994-03-23

ApplicantOrthotech
Decision Date1994-03-23
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOTECH DURA-GOLD BARCKETS is the device name listed in this FDA 510(k) record. The listed applicant is Orthotech. It received FDA 510(k) clearance on 1994-03-23 under 510(k) number K933080. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOTECH DURA-GOLD BARCKETS?

ORTHOTECH DURA-GOLD BARCKETS is a medical device that received FDA 510(k) clearance on 1994-03-23. The listed applicant is Orthotech. The 510(k) number is K933080.

When did ORTHOTECH DURA-GOLD BARCKETS receive FDA 510(k) clearance?

ORTHOTECH DURA-GOLD BARCKETS received FDA 510(k) clearance on 1994-03-23, under 510(k) number K933080.

Who is the listed applicant for ORTHOTECH DURA-GOLD BARCKETS?

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

What is the FDA product code for ORTHOTECH DURA-GOLD BARCKETS?

The FDA product code for ORTHOTECH DURA-GOLD BARCKETS is EJF.

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.

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Other records listing Orthotech 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.

K971453ORTHOTEC K-CAP SYSTEM

Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K935139FASCINATION CERAMIC BRACKETDentauraum, Inc.K936244REGENCY BRACKETMid-American Dental Specialties, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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