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FDA 510(k)

LINGUAL BRACKET

K-Number: K812300 · 1981-09-21

ApplicantAmerican Ormco
Decision Date1981-09-21
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LINGUAL BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is American Ormco. It received FDA 510(k) clearance on 1981-09-21 under 510(k) number K812300. 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 LINGUAL BRACKET?

LINGUAL BRACKET is a medical device that received FDA 510(k) clearance on 1981-09-21. The listed applicant is American Ormco. The 510(k) number is K812300.

When did LINGUAL BRACKET receive FDA 510(k) clearance?

LINGUAL BRACKET received FDA 510(k) clearance on 1981-09-21, under 510(k) number K812300.

Who is the listed applicant for LINGUAL BRACKET?

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

What is the FDA product code for LINGUAL BRACKET?

The FDA product code for LINGUAL 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 American Ormco 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.

K810241CRYSTAL-BOND

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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