510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K110468Substantially Equivalent

Freeway Comfort Bite Guard

Randmark Dental Products, LLC, Potomac MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110468 is the FDA 510(k) clearance record for FREEWAY COMFORT BITE GUARD, cleared for Randmark Dental Products, LLC on under FDA product code MQC (Mouthguard, Prescription). FDA records list one 510(k) clearance for Randmark Dental Products, LLC. As of , FDA records show no recalls naming K110468.

Clearance record

Decision date
Received
(169 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Randmark Dental Products, LLC 9109 Copenhaver Dr., Potomac MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQC

Trailing 12 months
3 clearances under product code MQC in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260