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FDA 510(k)

DIASTEMA CLOSING KIT

K-Number: K893542 · 1989-06-23

ApplicantAmerican Orthodontics
Decision Date1989-06-23
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIASTEMA CLOSING KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893542. 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 DIASTEMA CLOSING KIT?

DIASTEMA CLOSING KIT is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is American Orthodontics. The 510(k) number is K893542.

When did DIASTEMA CLOSING KIT receive FDA 510(k) clearance?

DIASTEMA CLOSING KIT received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893542.

Who is the listed applicant for DIASTEMA CLOSING KIT?

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 DIASTEMA CLOSING KIT?

The FDA product code for DIASTEMA CLOSING KIT is EJF.

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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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