Cleared Traditional

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

K251647 · Dentsply Sirona, Inc. · Dental

Aug 2025

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K251647 is an FDA 510(k) clearance for the MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on August 21, 2025, 84 days after receiving the submission on May 29, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K251647 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2025
Decision Date	August 21, 2025
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF