Cleared Traditional

K190107 - VeriSplint (FDA 510(k) Clearance)

K190107 · Whip Mix Corporation · Dental device
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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

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

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 70
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K190107.
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