MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
by MIS Implants Technologies Ltd. 510(k)
Active
510(k) K172505
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172505 | Date28 Dec 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- FDA applicant
- Mis Implants Technologies , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The MIS C1 system comprises a narrow‑platform conical‑connection dental implant and a wide‑platform conical‑connection abutment. Both components feature a 12‑degree friction‑fit conical interface designed to provide a secure seal, minimize micro‑movement, and support platform‑switching for improved bone‑implant contact and soft‑tissue preservation.
The device was cleared by the FDA through a traditional 510(k) submission (K172505) and is classified under product code DZE. It is supplied as a complete implant‑abutment system and is identified as substantially equivalent to a predicate device. The clearance indicates compliance with applicable U.S. regulatory requirements for dental implant devices.
Other devices from MIS Implants Technologies Ltd.
Questions
AI-generated answers, 24 Sep 2026
What clinical benefit does the 12‑degree friction‑fit conical interface provide?
The 12‑degree friction‑fit creates a tight seal between implant and abutment, limiting micro‑movement that can disrupt osseointegration. This stability helps maintain bone‑implant contact and preserves surrounding soft tissue, which can improve long‑term implant success.
How is the MIS C1 system supplied to the practitioner?
The system is delivered as a complete implant‑abutment package, containing the narrow‑platform conical‑connection implant and the matching wide‑platform conical‑connection abutment. Supplying both components together ensures the intended 12‑degree conical interface is used as designed.
Is the MIS C1 implant intended for single‑use or can it be reused?
Dental implants, including the MIS C1, are classified as single‑use devices. Once placed, the implant remains permanently in the patient’s bone, and the abutment is intended for one‑time attachment to maintain sterility and structural integrity.
What sizes or platform options are available in the MIS C1 system?
The system offers a narrow‑platform implant paired with a wide‑platform abutment. This combination enables platform‑switching, allowing clinicians to select the appropriate diameter for the implant site while using a broader abutment to optimize soft‑tissue support.
What regulatory pathway was used for the MIS C1 system’s clearance?
The MIS C1 system received clearance through a traditional 510(k) submission (K172505), indicating it was found substantially equivalent to a predicate dental implant device and meets the applicable U.S. regulatory requirements for dental implants.