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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K192069
Device Name Aerodentis System
Applicant
Dror Orthodesign
7 Hartom St., Mount Hotzvim
Jerusalem,  IL 9777507
Applicant Contact Michael Nadav
Correspondent
Hogan Lovelle US Llp
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number872.5470
Classification Product Code
NXC  
Date Received08/01/2019
Decision Date 05/06/2020
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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