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FDA 510(k)

ORTHODONTICARTIDE

K-Number: K800458 · 1980-03-25

ApplicantEuropean Orthodontic Products
Decision Date1980-03-25
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTICARTIDE is the device name listed in this FDA 510(k) record. The listed applicant is European Orthodontic Products. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800458. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTICARTIDE?

ORTHODONTICARTIDE is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is European Orthodontic Products. The 510(k) number is K800458.

When did ORTHODONTICARTIDE receive FDA 510(k) clearance?

ORTHODONTICARTIDE received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800458.

Who is the listed applicant for ORTHODONTICARTIDE?

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

What is the FDA product code for ORTHODONTICARTIDE?

The FDA product code for ORTHODONTICARTIDE is EBI.

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Related Devices (Code: EBI)

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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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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