Cleared Traditional

K241729 - Hard Splint & Thermo-Adaptive Splint (FDA 510(k) Clearance)

K241729 · Whip Mix Corporation · Dental device

Mar 2025

Decision

277d

Days

Risk

K241729 is an FDA 510(k) clearance for the Hard Splint & Thermo-Adaptive Splint. This device is classified as a Mouthguard, Prescription.

Submitted by Whip Mix Corporation (Louisville, US). The FDA issued a Cleared decision on March 18, 2025, 277 days after receiving the submission on June 14, 2024.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K241729 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 14, 2024
Decision Date	March 18, 2025
Days to Decision	277 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF