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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K171122
Device Name CEREC Ortho Software
Applicant
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York,  PA  17401
Applicant Contact Karl J. Nittinger
Correspondent
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York,  PA  17401
Correspondent Contact Karl J. Nittinger
Regulation Number872.5470
Classification Product Code
PNN  
Date Received04/17/2017
Decision Date 01/11/2018
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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