FDA 510(k)

Freeprint® denture flex

K-Number: K252430 · 2025-10-30

Decision Date2025-10-30

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Freeprint® denture flex is the device name listed in this FDA 510(k) record. The listed applicant is Detax GmbH. It received FDA 510(k) clearance on 2025-10-30 under 510(k) 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. The listed applicant is Detax GmbH. The 510(k) number is K252430.

When did Freeprint® denture flex receive FDA 510(k) clearance?

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

Who is the listed applicant for Freeprint® denture flex?

The FDA 510(k) record lists Detax GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Detax GmbH as applicant

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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Related Devices (Code: EBI)

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.