FDA.reportPublic FDA data

510(k) K222845

Device
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
Applicant
Frey Oral Technologies, LLC
510(k) number
K222845
Product code
MQC
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-28
Date received
2022-09-21
Classification name
Mouthguard, Prescription
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
David Frey
Address
433 N. Camden Dr., Suite 1070 Beverly Hills CA US 90210 90210

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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