Copra Smile, Copra Supreme Hyperion
K-Number: K233158 · 2024-06-20
ApplicantWhitepeaks Dental Solutions GmbH
Decision Date2024-06-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Copra Smile, Copra Supreme Hyperion is a medical device manufactured by Whitepeaks Dental Solutions GmbH. It received FDA 510(k) clearance on 2024-06-20 under approval number K233158. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Copra Smile, Copra Supreme Hyperion?
Copra Smile, Copra Supreme Hyperion is a medical device that received FDA 510(k) clearance on 2024-06-20. It is manufactured by Whitepeaks Dental Solutions GmbH. The 510(k) number is K233158.
When was Copra Smile, Copra Supreme Hyperion approved by the FDA?
Copra Smile, Copra Supreme Hyperion received FDA 510(k) clearance on 2024-06-20, under approval number K233158.
What company makes Copra Smile, Copra Supreme Hyperion?
Copra Smile, Copra Supreme Hyperion is manufactured by Whitepeaks Dental Solutions GmbH.
What is the FDA product code for Copra Smile, Copra Supreme Hyperion?
The FDA product code for Copra Smile, Copra Supreme Hyperion is EIH.
Other Devices by Whitepeaks Dental Solutions GmbH
Related Devices (Code: EIH)
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.