Cleared Traditional

VeriSplint (K190107) - 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.

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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
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.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -