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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K131101
Device Name ITERO SOFTWARE
Applicant
CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY
2560 ORCHARD PKWY
SAN JOSE,  CA  95131
Applicant Contact MANAS M LELE
Correspondent
CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY
2560 ORCHARD PKWY
SAN JOSE,  CA  95131
Correspondent Contact MANAS M LELE
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
NOF  
Date Received04/19/2013
Decision Date 08/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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