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 a medical device manufactured by Creodent Prosthetics, Ltd.. It received FDA 510(k) clearance on 2022-10-13 under approval 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. It is manufactured by Creodent Prosthetics, Ltd.. The 510(k) number is K211427.
When was CREOKORREKT Aligners approved by the FDA?
CREOKORREKT Aligners received FDA 510(k) clearance on 2022-10-13, under approval number K211427.
What company makes CREOKORREKT Aligners?
CREOKORREKT Aligners is manufactured by Creodent Prosthetics, Ltd..
What is the FDA product code for CREOKORREKT Aligners?
The FDA product code for CREOKORREKT Aligners is NXC.
Other Devices by Creodent Prosthetics, Ltd.
Related Devices (Code: NXC)
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.