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FDA 510(k)

20/20 ORTHODONTIC CERAMIC BRACKET

K-Number: K890145 · 1989-03-13

ApplicantAmerican Orthodontics
Decision Date1989-03-13
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

20/20 ORTHODONTIC CERAMIC 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 1989-03-13 under 510(k) number K890145. 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 20/20 ORTHODONTIC CERAMIC BRACKET?

20/20 ORTHODONTIC CERAMIC BRACKET is a medical device that received FDA 510(k) clearance on 1989-03-13. The listed applicant is American Orthodontics. The 510(k) number is K890145.

When did 20/20 ORTHODONTIC CERAMIC BRACKET receive FDA 510(k) clearance?

20/20 ORTHODONTIC CERAMIC BRACKET received FDA 510(k) clearance on 1989-03-13, under 510(k) number K890145.

Who is the listed applicant for 20/20 ORTHODONTIC CERAMIC 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 20/20 ORTHODONTIC CERAMIC BRACKET?

The FDA product code for 20/20 ORTHODONTIC CERAMIC 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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