KJ Zirconia Implant System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- KJ Implant System EUDAMED
- Model / Reference
- Attachment EUDAMEDBL406 EUDAMEDRQH603 EUDAMEDSP57AN EUDAMEDDRG507 EUDAMEDCO38AN EUDAMEDRQ603 EUDAMEDInstrument EUDAMEDOFRFDSN-C EUDAMEDFixture EUDAMEDOPF3716 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800142886409 EUDAMED08800142893308 EUDAMED08800142895487 EUDAMED08800208637709 EUDAMED08800208637341 EUDAMED08800142893414 EUDAMED08800208605586 EUDAMED08800075782045 EUDAMED
- Basic UDI-DI
- 88001104IFS01BR EUDAMED88002086IFS05H7 EUDAMED88000757IFS01JG EUDAMED
- 510(k) Number
- K173116 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMEDP01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The KJ Zirconia Implant System is a dental implant device classified under the nomenclature for dental implants (Product Code: DZE). It features zirconia-coated titanium implants designed for osseointegration in the jawbone, providing a biocompatible and aesthetically pleasing solution for tooth replacement. The system includes implant bodies and abutments engineered for long-term stability and minimal tissue irritation. Its zirconia layer enhances corrosion resistance and reduces the risk of soft tissue recession compared to traditional titanium implants.
This system is supplied as a sterile, single-use implant kit, intended for use in dental clinics and oral surgery settings. The zirconia coating is applied via atomic layer deposition (ALD) for uniform coverage, ensuring consistent mechanical properties across components. The system adheres to FDA 510(k) clearance (K173116) and MDR compliance, with components sized for standard dental implant protocols. Storage requires protection from moisture and extreme temperatures, and proper sterilisation procedures must be followed as per manufacturer guidelines.
Frequently asked questions
What makes the zirconia coating on the KJ Zirconia Implant System different from traditional titanium implants, and how does it benefit patients?
The KJ Zirconia Implant System features a zirconia-coated titanium implant where the zirconia layer is applied uniformly via atomic layer deposition (ALD). This coating enhances corrosion resistance compared to uncoated titanium implants, reducing the risk of soft tissue recession and irritation. Additionally, zirconia’s biocompatibility and aesthetic properties make it a more visually pleasing option for tooth replacement, blending better with natural gum tissue.
Is the KJ Zirconia Implant System intended for reuse, or is it designed for single-use only? How should it be stored?
The KJ Zirconia Implant System is explicitly supplied as a sterile, single-use implant kit, meaning each component is intended for one patient only. To maintain sterility and integrity, storage must protect the system from moisture and extreme temperatures. Follow the manufacturer’s guidelines for proper sterilization procedures before use, as the zirconia coating and titanium base require careful handling to preserve their performance.
What sizes or models are available in the KJ Zirconia Implant System, and are they compatible with standard dental implant protocols?
The KJ Zirconia Implant System includes implant bodies and abutments sized to align with standard dental implant protocols, though exact dimensions or model variations (e.g., diameters, lengths, or platform designs) are not specified in the provided data. The system’s zirconia-coated titanium construction ensures compatibility with common surgical techniques while prioritizing osseointegration and tissue integration.
How does the zirconia coating affect the longevity or stability of the implant compared to uncoated titanium implants?
The zirconia coating in this system is designed to improve long-term stability by reducing corrosion and minimizing soft tissue irritation, which can contribute to implant failure over time. Traditional titanium implants lack this protective layer, potentially leading to higher risks of recession or inflammation. The ALD-applied zirconia ensures uniform coverage, which may help maintain implant integrity and reduce complications associated with osseointegration.
What regulatory pathways has the KJ Zirconia Implant System undergone, and how does this impact its use in clinical settings?
The system has undergone FDA 510(k) clearance (K173116) under the Traditional pathway, with a decision classified as Substantially Equivalent (SESE) to a predicate device, and it complies with MDR (Medical Device Regulation) standards. This means it has been evaluated for safety and performance against established benchmarks, allowing its use in dental clinics and oral surgery settings where compliance with these regulatory frameworks is required. Always verify local regulations before implementation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: KJ ZIRCONIA Implant System - GUDID - FDA.report, Atomic Layer Deposition of Zirconia on Titanium Implants ..., zimmer | tradekorea, IT'S SHOWTIME FOR IDS 2019 COLOGNE GERMANY | Dental ..., DENTAL IMPLANT COMPANIES
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173116 | Class II | Active |
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Manufacturer
- Manufacturer
- Kj Meditech Co., Ltd.
Sources (9)
- FDA 510(k) K173116 24 fields · synced Sep 18, 2026
- EUDAMED 389017ad-4af8-4028-ab4b-515c9974991e 61 fields · synced Aug 1, 2026
- EUDAMED 83b1e329-3cff-45a7-855c-de154cadf236 61 fields · synced Aug 1, 2026
- EUDAMED e4d3e1be-6abc-465a-8f71-de5ea9a45e8d 61 fields · synced Aug 1, 2026
- EUDAMED 10b41a2f-1d32-45ba-9307-ae355fc49136 61 fields · synced Sep 17, 2026
- EUDAMED c07bce79-e748-4113-abab-e01c80a40d85 61 fields · synced Sep 17, 2026
- EUDAMED 8f4da925-0e5e-4078-a743-edd17d498932 61 fields · synced Sep 17, 2026
- EUDAMED 9bf8277f-5c75-4519-932c-dbc726d1d03e 61 fields · synced Sep 17, 2026
- EUDAMED 2b18fca3-77d4-4148-85ce-a10eb22ce823 61 fields · synced Sep 17, 2026