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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K210886
Device Name MIS Lance+ Conical Connection Dental Implant System
Applicant
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Applicant Contact Karl J Nittinger
Correspondent
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Correspondent Contact Rebecca Sporer
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/25/2021
Decision Date 06/17/2021
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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