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Sign in to claim this brandKj Meditech
US
Last updated May 23, 2026
What Kj Meditech makes
Kj Meditech manufactures dental implant components, including preformed permanent and temporary suprastructures, one-piece and two-piece screw endosteal implants, and dental implant systems with varying surface treatments. Their portfolio also includes orthodontic devices such as anchoring screws and extraoral headgear, as well as dental implant analogs for laboratory use. The company produces both submerged implant systems and modular abutments designed for integration with dental implants.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, adhering to applicable regulatory requirements for dental and orthodontic devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Kj Meditech manufacture?
Kj Meditech specializes in dental and orthodontic devices. Their portfolio includes dental implant components such as permanent and temporary preformed suprastructures, one-piece and two-piece screw endosteal implants, and full dental implant systems. They also produce orthodontic tools like anchoring screws and extraoral headgear, as well as dental implant analogs for laboratory use. These devices are designed for dental restoration, orthodontic treatment, and implantology.
Where is Kj Meditech based, and what regulatory database lists its devices?
Kj Meditech is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a publicly accessible registry tracking medical devices authorized for use in the U.S. This database helps ensure transparency and traceability of their products under FDA regulations.
How are Kj Meditech’s devices classified under FDA regulations?
Kj Meditech’s devices fall under FDA’s Class I and Class II classifications. Class I generally includes low-risk devices like dental implant analogs or minor orthodontic tools, while Class II covers moderate-risk items such as dental implant systems and suprastructures, which require special controls to ensure safety and effectiveness. The classification depends on factors like intended use, risk level, and regulatory history.
What kinds of dental implant systems does Kj Meditech produce, and how do they differ?
Kj Meditech manufactures a range of dental implant systems, including one-piece and two-piece screw endosteal implants, which integrate directly into the jawbone. Their portfolio also includes systems with different surface treatments (e.g., SLA or HA), designed to improve osseointegration. Temporary and permanent preformed suprastructures are additional components, while submerged implant systems (like the KJ SUBMERGED SYSTEM) allow for controlled healing beneath the gumline. Modular abutments further enable customization for patient-specific restorations.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (2116)
Page 43 of 43| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KJ SUBMERGED SYSTEM - Solid Abutment | SDC24010S | FDA UDI | Class II | Active |
| Two-Piece Type Abutments | TWA505530R | FDA UDI | Class II | Active |
| KJ SUBMERGED SYSTEM - Solid Abutment | SDA25080S | FDA UDI | Class II | Active |
| Hero I Dental Implant System | K121098 | FDA 510(k) | Class II | Active |
| KJ Mini Implant System | K151970 | FDA 510(k) | Class II | Active |
| Hero Ii Dental Implant System, Is Dental Implant System | K121047 | FDA 510(k) | Class II | Active |
| J2A Dental Implant System, J2C Dental Implant System | K150060 | FDA 510(k) | Class II | Active |
| J2i Implant System | K140052 | FDA 510(k) | Class II | Active |
| Kj External Implant System | K140051 | FDA 510(k) | Class II | Active |
| Kj Mask | K103019 | FDA 510(k) | Class II | Active |
| KJ ZIRCONIA Implant System | K173116 | EUDAMEDFDA 510(k) | Class II | Active |
| LOTA SLA Dental Implant System and LOTA HA Dental Implant System | K202046 | FDA 510(k) | Class II | Active |
| Kj Submerged System | K103810 | FDA 510(k) | Class II | Active |
| J2A SLA Dental Implant System | K161923 | FDA 510(k) | Class II | Active |
| Kerator | K112787 | FDA 510(k) | Class II | Active |
| Anchor Plus/Neo Anchor Plus | K053629 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Kj Meditech Co., Ltd. Gwangju · KR FEI 3008959419