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FDA 510(k)

APEX DIRECT BONDED BRACKETS

K-Number: K923440 · 1993-03-31

ApplicantApex Orthodontics, Inc.
Decision Date1993-03-31
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APEX DIRECT BONDED BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is Apex Orthodontics, Inc.. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K923440. 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 APEX DIRECT BONDED BRACKETS?

APEX DIRECT BONDED BRACKETS is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Apex Orthodontics, Inc.. The 510(k) number is K923440.

When did APEX DIRECT BONDED BRACKETS receive FDA 510(k) clearance?

APEX DIRECT BONDED BRACKETS received FDA 510(k) clearance on 1993-03-31, under 510(k) number K923440.

Who is the listed applicant for APEX DIRECT BONDED BRACKETS?

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

What is the FDA product code for APEX DIRECT BONDED BRACKETS?

The FDA product code for APEX DIRECT BONDED BRACKETS 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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