Cleared Abbreviated

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

K250969 · Dent4you AG · Dental
Jun 2025
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K250969 is an FDA 510(k) clearance for the JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on June 27, 2025, 88 days after receiving the submission on March 31, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K250969 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date June 27, 2025
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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