Cleared Abbreviated

K250969 - JET BITE (FDA 510(k) Clearance)

Also includes:
JET BLUE BITE FAST JET BLUE BITE SUPERFAST

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K250969 · Dent4you AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
88d
Days
Class 2
Risk

K250969 is an FDA 510(k) clearance for the JET BITE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on June 27, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dent4you AG devices

Submission Details

510(k) Number K250969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 401
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