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MIS Lance+ Conical Connection Dental Implant System

by Dentsply Sirona 510(k)

Active United States

510(k) K210886

Overview

The MIS Lance+ Conical Connection Dental Implant System is a dental implant designed for osseointegration in the jawbone, featuring a conical connection interface between the implant and abutment. This system is categorized under dental implants with a specialized conical geometry to enhance stability and reduce micro-movements. Its design aims to minimize bacterial leakage while supporting long-term integration with surrounding tissues. The conical connection ensures a secure fit, improving both mechanical stability and biological compatibility for restorative procedures.

This system is supplied as a sterile, single-use or reusable component set depending on the included instruments and surgical tools. It is intended for use in oral and maxillofacial surgery settings, adhering to standard aseptic protocols. The conical connection design is compatible with MRI environments, as no magnetic or ferromagnetic materials are specified in the device specifications. Sizes and configurations are tailored for various clinical indications, including single-tooth replacement and full-arch restoration. The device holds FDA 510(k) clearance under the Traditional review pathway, classified under product code DZE for dental implants.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210886 Date17 Jun 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the MIS Lance+ Conical Connection Dental Implant System designed for?

    The MIS Lance+ Conical Connection Dental Implant System is specifically designed for osseointegration in the jawbone, providing a stable foundation for dental restorations. Its conical connection interface between the implant and abutment reduces micro-movements, minimizes bacterial leakage, and supports long-term integration with surrounding tissues. This design is particularly suited for single-tooth replacement and full-arch restoration procedures.

  • How is the MIS Lance+ Conical Connection Dental Implant System supplied, and what does this mean for clinical use?

    The system is supplied as a sterile set, with components available as either single-use or reusable, depending on the included instruments and tools. Single-use components ensure patient safety by eliminating cross-contamination risks, while reusable instruments can be sterilized between procedures following strict aseptic protocols. Clinicians should follow manufacturer guidelines to determine which components are intended for single-use and which can be reused.

  • Are the implants compatible with MRI environments, and why?

    Yes, the MIS Lance+ Conical Connection Dental Implant System is designed to be compatible with MRI environments. This is because the conical connection design does not include magnetic or ferromagnetic materials, reducing the risk of interference or artifacts during MRI scans. Clinicians should verify this compatibility with the manufacturer’s documentation before use in patients requiring MRI imaging.

  • What sizes and configurations are available for the MIS Lance+ Conical Connection Dental Implant System?

    The system offers tailored sizes and configurations to address various clinical indications, including single-tooth replacement and full-arch restoration. Exact dimensions and configurations should be referenced in the manufacturer’s product catalog or technical specifications. These variations allow for customization based on patient anatomy and treatment planning.

  • How should the MIS Lance+ Conical Connection Dental Implant System be stored to maintain sterility and functionality?

    To maintain sterility and functionality, the system should be stored in a clean, dry environment protected from moisture, dust, and extreme temperatures. Single-use components should remain in their original, sealed packaging until use. Reusable instruments should be stored in a dedicated, sterilized case or container, following the manufacturer’s instructions for cleaning and sterilization protocols to ensure they remain safe and effective for subsequent procedures.