FDA · official record K251647Substantially Equivalent

MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System

Name: MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System — FDA K251647
Creator: Dentsply Sirona, Inc.
Keywords: MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System, MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System, K251647, DZE, FDA

United StatesDZEDentsply Sirona, Inc.

Verified

Official record identity

FDA application number: K251647
Decision date: August 21, 2025
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Dentsply Sirona, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2025-05-29
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.