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FDA 510(k)

ORTHODONTIC METAL BRACKET

K-Number: K923261 · 1992-12-03

ApplicantAmerican Orthodontics
Decision Date1992-12-03
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC METAL BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1992-12-03 under 510(k) number K923261. 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 ORTHODONTIC METAL BRACKET?

ORTHODONTIC METAL BRACKET is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is American Orthodontics. The 510(k) number is K923261.

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

ORTHODONTIC METAL BRACKET received FDA 510(k) clearance on 1992-12-03, under 510(k) number K923261.

Who is the listed applicant for ORTHODONTIC METAL BRACKET?

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

What is the FDA product code for ORTHODONTIC METAL BRACKET?

The FDA product code for ORTHODONTIC METAL BRACKET is EJF.

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Other records listing American Orthodontics as applicant

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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

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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