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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dental abutment design software for dental laboratory
510(k) Number K200191
Device Name Sirona Dental CAD/CAM System with InLab Software
Applicant
Dentsply Sirona
221 West Philadelphia St., Suite 60W
York,  PA  17401
Applicant Contact Karl J. Nittinger
Correspondent
Dentsply Sirona
221 West Philadelphia St., Suite 60W
York,  PA  17401
Correspondent Contact Karl J. Nittinger
Regulation Number872.3630
Classification Product Code
PNP  
Date Received01/27/2020
Decision Date 08/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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