Cleared Traditional

K190107 - VeriSplint (FDA 510(k) Clearance)

K190107 · Whip Mix Corporation · Dental device

Jul 2019

Decision

169d

Days

Risk

K190107 is an FDA 510(k) clearance for the VeriSplint. This device is classified as a Mouthguard, Prescription.

Submitted by Whip Mix Corporation (Louisville, US). The FDA issued a Cleared decision on July 10, 2019, 169 days after receiving the submission on January 22, 2019.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K190107 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 22, 2019
Decision Date	July 10, 2019
Days to Decision	169 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF