Cristaline Aligners Z FLX
K-Number: K242892 · 2024-12-19
ApplicantCristaline Aligners GmbH
Decision Date2024-12-19
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Cristaline Aligners Z FLX is a medical device manufactured by Cristaline Aligners GmbH. It received FDA 510(k) clearance on 2024-12-19 under approval number K242892. 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 Cristaline Aligners Z FLX?
Cristaline Aligners Z FLX is a medical device that received FDA 510(k) clearance on 2024-12-19. It is manufactured by Cristaline Aligners GmbH. The 510(k) number is K242892.
When was Cristaline Aligners Z FLX approved by the FDA?
Cristaline Aligners Z FLX received FDA 510(k) clearance on 2024-12-19, under approval number K242892.
What company makes Cristaline Aligners Z FLX?
Cristaline Aligners Z FLX is manufactured by Cristaline Aligners GmbH.
What is the FDA product code for Cristaline Aligners Z FLX?
The FDA product code for Cristaline Aligners Z FLX is NXC.
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.