Cleared Traditional

VeriSplint

K190107 · Whip Mix Corporation · Dental
Jul 2019
Decision
169d
Days
—
Risk

About This 510(k) Submission

K190107 is an FDA 510(k) clearance for the VeriSplint, 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 review panel.

Submission Details

510(k) Number K190107 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —