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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 K213449
Device Name DS Implants abutments provided with the EV connection
Applicant
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York,  PA  17401
Applicant Contact Courtney Clark
Correspondent
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York,  PA  17401
Correspondent Contact Courtney Clark
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/26/2021
Decision Date 11/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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