KIS MT5

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K960112 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Kis-V Pre-Angulated and Wide Body Abutments

  Class II

  FDA 510(k) K950893 Active Cleared 5 May 1995

• Abutment - Complete

  Class II

  FDA 510(k) K974280 Active Cleared 20 Feb 1998

• Screw Implants, Grade 3; Uncoated, Ha, Tp-B3

  Class II

  FDA 510(k) K953234 Active Cleared 8 Nov 1995

• Kis II Lg Hex Screw & Cylinder Implants

  Class II

  FDA 510(k) K953558 Active Cleared 19 Dec 1995

• Prosthetics & Instrumentation a. Prosthetic Abutments 4, 5, 6 Diameter, Grade 3, B. Irrigation Drills, Tooling & Preang'

  Class II

  FDA 510(k) K953237 Active Cleared 15 Sep 1995

• Kis MT3

  Class II

  FDA 510(k) K960110 Active Cleared 20 Mar 1996

See all devices from The Implant Center of the Palm Beaches →

• What is the KIS MT5 used for in dental implant procedures?

  The KIS MT5 is a dental implant abutment system designed to connect prosthetic crowns, bridges, or other restorations to dental implants. It transfers occlusal forces from the restoration to the implant fixture, ensuring stability and proper function of the dental prosthesis. This is critical for long-term success in implant-supported restorations.

• Is the KIS MT5 intended for single-use or reusable in a clinical setting?

  The KIS MT5 is supplied as a reusable device, intended for use in clinical dental settings by trained professionals. However, it must be properly sterilized between patients to comply with single-patient-use protocols in dental implant procedures. This ensures patient safety and prevents cross-contamination.

• How is the sterility of the KIS MT5 managed before clinical use?

  The KIS MT5 is provided in a non-sterile state, meaning it must undergo sterilization by the dental clinic or practitioner before use. Proper sterilization procedures, such as autoclaving or chemical sterilization, are required to ensure the device is safe for each patient. This aligns with standard dental implant protocols to maintain hygiene and infection control.

• Does the KIS MT5 come in different sizes or models?

  The available data does not specify any size variations or additional models for the KIS MT5. It is designed as a single system for dental abutment applications, adhering to the product code DZE for dental abutments and connectors. Clinicians should confirm compatibility with their specific implant systems and restorative needs.

• What regulatory pathway does the KIS MT5 follow, and who oversees its approval?

  The KIS MT5 is regulated under the FDA 510(k) clearance process, with the clearance number K960112. It falls under the Dental advisory committee (DE) review panel and is classified as substantially equivalent to predicate devices. The Implant Center of the Palm Beaches is the applicant responsible for the submission and compliance.