Freeprint® denture flex— 510(k) K252430

Name: FDA 510(k) clearance K252430
Creator: U.S. Food and Drug Administration
Published: 2025-10-30

Substantially Equivalent

Detax GmbH

FDA 510(k) clearance K252430 for Freeprint® denture flex, Substantially Equivalent on 2025-10-30. Applicant: Detax GmbH. Device class: 2.

Clearance details

Applicant: Detax GmbH
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2025-08-01
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ettingen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

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K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

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K232448 — FREEPRINT® splintmaster2023-10-12
K222877 — FREEPRINT crown2022-09-23

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.