FDA.reportPublic FDA data

510(k) K250743

Device
Remvia NightGuard
Applicant
Remvia
510(k) number
K250743
Product code
MQC
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-05
Date received
2025-03-11
Classification name
Mouthguard, Prescription
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Nephi Zufelt
Address
911 Washington Ave. #500 St. Louis MO US 63101 63101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K230592LuxCreo Dental Night Guard ResinLuxCreo, Inc.2024-01-18
K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC2023-11-28
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