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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Caries Detector, Laser Light, Transmission
510(k) Number K193659
Device Name iTero Element 5D
Applicant
Align Technology, Inc.
2820 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact Angela M. Frederickson
Correspondent
Hogan Lovells US LLP
1601 Wewatta St., #900
Denver,  CO  80202
Correspondent Contact Angela Frederickson
Regulation Number872.1745
Classification Product Code
NTK  
Date Received12/30/2019
Decision Date 03/20/2020
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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