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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 K211225
Device Name MIS Ti-base abutment
Applicant
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Applicant Contact Rebecca Sporer
Correspondent
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Correspondent Contact Rebecca Sporer
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/23/2021
Decision Date 07/28/2021
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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