Magicore II System
by Innobiosurg Co., Ltd. 510(k)
Active
510(k) K192197
Overview
The Magicore II System is a dental implant device designed for the replacement of missing teeth to restore chewing function. Classified under dental implant nomenclature, it supports single or multiple-unit restorations, including cement-retained or overdenture applications, providing structural support for prosthetic teeth.
This system is intended for use in oral and maxillofacial surgical settings and is supplied as a sterile, single-use implant. It is regulated under FDA 510(k) clearance (K192197) with a traditional review pathway, adhering to dental implant standards. Sizes and configurations are specified in the manufacturer’s documentation, and proper handling requires adherence to sterile surgical protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192197 | Date28 Apr 2020 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Innobiosurg Co., Ltd.
Questions
What types of dental restorations can the Magicore II System support, and how does it differ from other dental implants in this regard?
The Magicore II System is specifically designed to support both single and multiple-unit restorations, including cement-retained crowns or bridges as well as overdentures. Unlike some implants that may only be suitable for single-tooth replacements, this system provides versatility for broader prosthetic needs, such as restoring multiple missing teeth or securing removable dentures. Its structural design ensures stability for these applications in oral and maxillofacial surgical settings.
Is the Magicore II System intended for reuse, or is it meant to be used only once per patient? How does this affect its handling?
The Magicore II System is supplied as a sterile, single-use implant, meaning each unit is intended for one surgical procedure per patient. This design minimizes infection risks and ensures consistent sterility, requiring strict adherence to sterile surgical protocols during handling and implantation. Reuse is not recommended, as it could compromise patient safety and device integrity.
How are the different sizes and configurations of the Magicore II System determined, and where can a clinician find this information?
The Magicore II System’s sizes and configurations are detailed in the manufacturer’s accompanying documentation, which specifies the variations available for clinical use. These specifications are tailored to accommodate diverse patient anatomies and restoration needs, such as varying implant lengths or diameters. Clinicians should refer to the provided technical manuals or consult Innobiosurg Co., Ltd. for precise sizing guidance before surgery.
What surgical environment is the Magicore II System intended for, and what precautions should be taken during its use?
The Magicore II System is designed exclusively for oral and maxillofacial surgical settings, where controlled sterile conditions are maintained. Since it is sterile and single-use, clinicians must follow strict aseptic techniques during handling, implantation, and post-operative care. Improper storage or exposure could compromise sterility, so it should be kept in its original packaging until immediately before use.
What regulatory pathway was followed for the FDA clearance of the Magicore II System, and what does this mean for clinicians?
The Magicore II System received FDA clearance through a 510(k) traditional review pathway, classified under dental implant standards (product code DZE) and reviewed by the Dental (DE) Advisory Committee. This means the device was evaluated for substantial equivalence to a legally marketed predicate, ensuring it meets established safety and performance criteria for dental implants. Clinicians can rely on this clearance as evidence of the system’s regulatory compliance for single or multiple-unit restorations.