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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K243752
Device Name Double Tube Herbst Appliance
Applicant
The Tmj Clinic PC
833 SW 11th Ave.
# 810
Portland,  OR  97205
Applicant Contact John Summer
Correspondent
The Tmj Clinic PC
833 SW 11th Ave.
# 810
Portland,  OR  97205
Correspondent Contact John Summer
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received12/05/2024
Decision Date 09/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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