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FDA 510(k)

GEM II ORTHODONTIC BRACKET

K-Number: K892704 · 1989-06-12

ApplicantOrmco Corp.
Decision Date1989-06-12
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GEM II ORTHODONTIC BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K892704. 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 GEM II ORTHODONTIC BRACKET?

GEM II ORTHODONTIC BRACKET is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Ormco Corp.. The 510(k) number is K892704.

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

GEM II ORTHODONTIC BRACKET received FDA 510(k) clearance on 1989-06-12, under 510(k) number K892704.

Who is the listed applicant for GEM II ORTHODONTIC BRACKET?

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 GEM II ORTHODONTIC BRACKET?

The FDA product code for GEM II ORTHODONTIC BRACKET is EJF.

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Other records listing Ormco Corp. 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.

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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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