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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K192581
Device Name The NightBlocks Appliance
Applicant
Advanced Facialdontics, LLC
325 Lake Ave. Unit 759
St James,  NY  11780
Applicant Contact Scott Simonetti
Correspondent
Advanced Facialdontics, LLC
325 Lake Ave. Unit 759
St James,  NY  11780
Correspondent Contact Scott Simonetti
Regulation Number872.5570
Classification Product Code
LQZ  
Subsequent Product Code
LRK  
Date Received09/19/2019
Decision Date 01/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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