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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 K251647
Device Name MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Melanie Avila
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Melanie Avila
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/29/2025
Decision Date 08/21/2025
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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