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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Implant, Dental, Endosseous
510(k) Number K193405
Device Name Simplant Digital Guide
Applicant
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Applicant Contact Karl Nittinger
Correspondent
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Correspondent Contact Karl Nittinger
Regulation Number872.3980
Classification Product Code
NDP  
Date Received12/09/2019
Decision Date 09/02/2020
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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