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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K212767
Device Name SleepRight Select-Comfort Dental Guard
Applicant
Splintek, Inc.
15555 W. 108th St.
Lenexa,  KS  66219
Applicant Contact Thomas W. Brown
Correspondent
Splintek, Inc.
15555 W. 108th St.
Lenexa,  KS  66219
Correspondent Contact Thomas W. Brown
Classification Product Code
MQC  
Subsequent Product Code
OBR  
Date Received08/31/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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