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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 K221322
Device Name CUSTMBITE Snoring System
Applicant
Dental Choice Holdings LLC
10100 Linn Station Road
Louisville,  KY  40223
Applicant Contact Danielle M Jackson
Correspondent
Smith Associates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number872.5570
Classification Product Code
LRK  
Date Received05/06/2022
Decision Date 10/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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