Freeprint® denture flex
FDA 510(k) K252430 · Detax GmbH
510(k) numberK252430
Submission
- Device name
- Freeprint® denture flex
- Applicant
- Detax GmbH
Ettingen, DE - Received
- August 1, 2025
- Decision date
- October 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K162654 | mollosil plusEBI · Traditional | 03/13/2017SE |
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Questions and answers
When was Freeprint® denture flex cleared by the FDA?
Freeprint® denture flex (K252430) received a 510(k) decision of Substantially Equivalent on October 30, 2025, 90 days after the submission was received.
What is the product code of K252430?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.