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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 K172991
Device Name Advanced Dental Applicance
Applicant
DaSoft Partners
4079 Governer Drive
#111
San Diego,  CA  92122
Applicant Contact Dante Togliatti
Correspondent
ASchwartz Consulting
1225 Hall Road
West Chester,  PA  19380
Correspondent Contact Alyssa Schwartz
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/27/2017
Decision Date 07/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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