Cleared Traditional

MIGRA TAB, QUICKSPLINT MIGRAINE (K111066) - FDA 510(k) Clearance

K111066 · Migratherapy, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
218d
Days
-
Risk

K111066 is an FDA 510(k) clearance for the MIGRA TAB, QUICKSPLINT MIGRAINE. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Migratherapy, LLC (Encinitas, US). The FDA issued a Cleared decision on November 22, 2011 after a review of 218 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 Migratherapy, LLC devices

Submission Details

510(k) Number K111066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2011
Decision Date November 22, 2011
Days to Decision 218 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
91d slower than avg
Panel avg: 127d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 70
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