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FDA 510(k)

GLENROE GOLDEN ORTHODONTIC BRACKET

K-Number: K923124 · 1992-08-27

ApplicantGlenroe
Decision Date1992-08-27
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLENROE GOLDEN ORTHODONTIC BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Glenroe. It received FDA 510(k) clearance on 1992-08-27 under 510(k) number K923124. 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 GLENROE GOLDEN ORTHODONTIC BRACKET?

GLENROE GOLDEN ORTHODONTIC BRACKET is a medical device that received FDA 510(k) clearance on 1992-08-27. The listed applicant is Glenroe. The 510(k) number is K923124.

When did GLENROE GOLDEN ORTHODONTIC BRACKET receive FDA 510(k) clearance?

GLENROE GOLDEN ORTHODONTIC BRACKET received FDA 510(k) clearance on 1992-08-27, under 510(k) number K923124.

Who is the listed applicant for GLENROE GOLDEN ORTHODONTIC BRACKET?

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

What is the FDA product code for GLENROE GOLDEN ORTHODONTIC BRACKET?

The FDA product code for GLENROE GOLDEN ORTHODONTIC BRACKET 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 Glenroe 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.

K973495GLENROE GLOW IN DARK ELASTOMERIC LIGATURES

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.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, 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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