Cleared Traditional

K110468 - FREEWAY COMFORT BITE GUARD

K110468 · Randmark Dental Products, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
169d
Days
-
Risk

K110468 is an FDA 510(k) clearance for the FREEWAY COMFORT BITE GUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Randmark Dental Products, LLC (Potomac, US). The FDA issued a Cleared decision on August 5, 2011 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.

FDA 510(k) Submission Details - K110468

510(k) Number K110468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2011
Decision Date August 05, 2011
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
41d slower than avg
Panel avg: 128d · 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 71
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K110468 · FREEWAY COMFORT BITE GUARD
Download PDF FDA Summary Randmark Dental Produ…