Skip to content

CSM Internal-R Implant System

by Csm Implant 510(k)

Active United States

510(k) K120043

Overview

The CSM Internal-R Implant System is an endosseous root-form dental implant designed for use in partial or fully edentulous mandibles and maxillae. It provides support for single or multiple-unit restorations, featuring two fixture types—straight and tapered—constructed from titanium alloy (Ti-6Al-4V ELI).

The system is supplied as a reusable, non-sterile medical device intended for surgical placement by dental professionals. Fixtures undergo a Resorbable hydroxyapatite Blast surface treatment to enhance osseointegration. Authorized under FDA 510(k) clearance (K120043), it adheres to dental implant standards and is classified under product code DZE.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120043 Date27 Apr 2012ClearedStatusActive

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

Other devices from Csm Implant Co., Ltd.

Questions

  • What types of dental restorations can the CSM Internal-R Implant System support, and how does the fixture design contribute to stability?

    The CSM Internal-R Implant System is designed to support both single and multiple-unit dental restorations in partially or fully edentulous mandibles and maxillae. It offers two fixture types—straight and tapered—to accommodate different anatomical needs. The tapered design may provide enhanced stability by distributing forces more effectively along the bone interface, while the Resorbable Hydroxyapatite Blast surface treatment promotes osseointegration, improving long-term fixation in the jawbone.

  • Is the CSM Internal-R Implant System intended for single-use or can it be reused in multiple procedures?

    The CSM Internal-R Implant System is explicitly supplied as a reusable medical device, not intended for single-use. However, it is provided in a non-sterile state, meaning it must be sterilized by the dental practice prior to surgical use. This allows for multiple procedures as long as proper sterilization protocols are followed.

  • What materials are the fixtures made from, and why is this material choice significant?

    The fixtures in the CSM Internal-R Implant System are constructed from titanium alloy (Ti-6Al-4V ELI), a biocompatible material commonly used in dental implants due to its strength, corrosion resistance, and compatibility with bone tissue. The ELI (Extra Low Interstitial) grade ensures minimal allergic reactions, making it suitable for long-term implantation in the jawbone.

  • How should the CSM Internal-R Implant System be stored before use, and what considerations should be taken into account?

    Since the system is non-sterile and reusable, it should be stored in a clean, dry environment protected from contamination until sterilization. The packaging must remain intact until ready for sterilization to prevent exposure to dust, moisture, or other contaminants. After sterilization, it should be stored in accordance with the facility’s protocols to maintain sterility for surgical use.