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FDA 510(k)

Freeprint® denture flex

K-Number: K252430 · 2025-10-30

ApplicantDetax GmbH
Decision Date2025-10-30
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Freeprint® denture flex is a medical device manufactured by Detax GmbH. It received FDA 510(k) clearance on 2025-10-30 under approval number K252430. 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 Freeprint® denture flex?

Freeprint® denture flex is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Detax GmbH. The 510(k) number is K252430.

When was Freeprint® denture flex approved by the FDA?

Freeprint® denture flex received FDA 510(k) clearance on 2025-10-30, under approval number K252430.

What company makes Freeprint® denture flex?

Freeprint® denture flex is manufactured by Detax GmbH.

What is the FDA product code for Freeprint® denture flex?

The FDA product code for Freeprint® denture flex is EBI.

Other Devices by Detax GmbH

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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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