LOCKiT Abutments System, OT-Equators and Ball Attachments
by MIS Implants Technologies Ltd.
510(k) K182228
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182228 | Date28 Jan 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
- 510(k) Number
- FDA Product Code
- NHA
- FDA applicant
- Mis Implants Technologies , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The LOCKiT Abutments System, OT-Equators and Ball Attachments is a dental implant abutment system designed for connecting overdentures to endosseous dental implants. It includes titanium abutments with a titanium nitride (TiN) coating, OT-Equators for precise alignment, and ball attachments to enhance retention of implant-supported overdentures. The system is intended for use in dental prosthetics, providing stability and secure attachment for tissue-supported implant-retained overdentures. Compatibility is ensured with MIS internal hex and conical connection implants.
This system is supplied as a sterile, single-use or reusable component set, depending on the specific attachments included. The ball attachments are engineered to improve retention and stabilization of overdentures, while OT-Equators facilitate accurate torque control and positioning. The device is regulated under FDA 510(k) clearance (K182228) as a dental implant component, adhering to traditional review standards. Storage and handling follow standard sterile protocols for dental implant hardware, with sizes and configurations tailored for endosseous implant integration.
Other devices from MIS Implants Technologies Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the MIS LOCKiT Abutments System designed for?
The MIS LOCKiT Abutments System is specifically designed to connect overdentures to endosseous dental implants, providing stability and secure attachment for tissue-supported implant-retained overdentures. The system includes titanium abutments with a titanium nitride (TiN) coating, OT-Equators for precise alignment, and ball attachments to enhance retention. This ensures a reliable fit for overdentures in dental prosthetics.
How is the LOCKiT Abutments System supplied, and what does this mean for reuse?
The LOCKiT Abutments System is supplied as either a sterile single-use or reusable component set, depending on the specific attachments included. Single-use components are intended for one-time clinical application to maintain sterility and reduce cross-contamination risks, while reusable parts are designed for multiple uses under strict sterilization protocols. Always follow manufacturer guidelines for sterilization and handling to ensure safety and functionality.
Are the ball attachments part of the LOCKiT System, and how do they improve overdenture stability?
Yes, the ball attachments are an integral part of the LOCKiT Abutments System. They are engineered to improve retention and stabilization of overdentures by creating a secure mechanical lock with the corresponding components. This design minimizes movement and enhances comfort for patients wearing implant-supported overdentures, ensuring long-term stability.
What types of dental implants is this system compatible with?
The LOCKiT Abutments System is designed for compatibility with MIS internal hex and conical connection implants. This ensures a precise fit and secure attachment between the abutments and the implant fixtures, facilitating accurate torque control and optimal positioning for overdenture stability.
How should the LOCKiT Abutments System be stored, and what considerations apply?
The system should be stored following standard sterile protocols for dental implant hardware to maintain its integrity and sterility. This includes keeping components in a clean, dry environment, away from direct sunlight or extreme temperatures, and using sealed packaging if provided. Always refer to the manufacturer’s instructions for specific storage guidelines to ensure longevity and readiness for clinical use.