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FDA 510(k)

CREOKORREKT Aligners

K-Number: K211427 · 2022-10-13

ApplicantCreodent Prosthetics, Ltd.
Decision Date2022-10-13
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CREOKORREKT Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Creodent Prosthetics, Ltd.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K211427. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREOKORREKT Aligners?

CREOKORREKT Aligners is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Creodent Prosthetics, Ltd.. The 510(k) number is K211427.

When did CREOKORREKT Aligners receive FDA 510(k) clearance?

CREOKORREKT Aligners received FDA 510(k) clearance on 2022-10-13, under 510(k) number K211427.

Who is the listed applicant for CREOKORREKT Aligners?

The FDA 510(k) record lists Creodent Prosthetics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREOKORREKT Aligners?

The FDA product code for CREOKORREKT Aligners is NXC.

Other records listing Creodent Prosthetics, Ltd. as applicant

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Related Devices (Code: NXC)

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

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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