JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST— 510(k) K250969

Name: FDA 510(k) clearance K250969
Creator: U.S. Food and Drug Administration
Published: 2025-06-27

Substantially Equivalent

Dent4you AG

FDA 510(k) clearance K250969 for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST, Substantially Equivalent on 2025-06-27. Applicant: Dent4you AG. Device class: 2.

Clearance details

Applicant: Dent4you AG
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2025-03-31
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Heerbrugg, CH

Download summary PDF View on FDA.gov ↗

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