510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K222845Substantially Equivalent

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece

Frey Oral Technologies, LLC, Beverly Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222845 is the FDA 510(k) clearance record for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece, cleared for Frey Oral Technologies, LLC on under FDA product code MQC (Mouthguard, Prescription). FDA records list one 510(k) clearance for Frey Oral Technologies, LLC. As of , FDA records show no recalls naming K222845.

Clearance record

Decision date
Received
(433 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Frey Oral Technologies, LLC 433 N. Camden Dr., Suite 1070, Beverly Hills CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQC

Trailing 12 months
2 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 20260
October 20260