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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 K183270
Device Name Silent Nite sl
Applicant
Prismatik Dentalcraft, Inc.
2181 Dupont Dr.
Irvine,  CA  92612
Applicant Contact Mythili Reguraman
Correspondent
Prismatik Dentalcraft, Inc.
2181 Dupont Dr.
Irvine,  CA  92612
Correspondent Contact Mythili Reguraman
Regulation Number872.5570
Classification Product Code
LRK  
Date Received11/23/2018
Decision Date 07/17/2019
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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