Cleared Traditional

K190107 - VeriSplint

K190107 · Whip Mix Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
169d
Days
-
Risk

K190107 is an FDA 510(k) clearance for the VeriSplint. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Whip Mix Corporation (Louisville, US). The FDA issued a Cleared decision on July 10, 2019 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Whip Mix Corporation devices

FDA 510(k) Submission Details - K190107

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 42
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K190107.
Ceramill A-Splint
K191836 · Amann Girrbach AG · Dec 2019
KeyPrint KeySplint Soft
K183598 · Keystone Industries · Nov 2019
The POD
K182820 · Advanced Facialdontics, LLC · Jul 2019
Brux Night Guard
K181361 · Brux Night Guard · Apr 2019
THERMOFORM SHEET MATERIALS AND ACCESSORIES
K072522 · Dentsply International, Inc. · Nov 2007
PRIMOSPLINT SYSTEM
K030832 · Cosmedent, Inc. · Sep 2003