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KJ Submerged System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103810

by Kj Meditech Co., Ltd.

Identifiers

510(k) Number
K103810 FDA 510(k)
FDA Product Code
DZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The KJ Submerged System is a dental implant abutment designed for use in partially or fully edentulous mandibles and maxillae. It supports single or multiple-unit restorations, including cemented, screw-retained, or overdenture attachments, as well as terminal or intermediate restorative solutions.

This system is supplied as a combination product and is intended for submerged placement during the osseointegration phase of dental implant therapy. It is cleared under FDA 510(k) with the product code DZE, classified under the Dental advisory committee. The model number SDC25010S is specified for the solid abutment variant, and the device is regulated as a traditional 510(k) submission with no PCCP authorization.

Frequently asked questions

What types of dental restorations can the KJ Submerged System support, and how does it differ from standard abutments in its approach?

The KJ Submerged System is specifically designed to support single or multiple-unit restorations, including cemented crowns, screw-retained restorations, overdenture attachments, and terminal or intermediate restorative solutions for partially or fully edentulous patients. Unlike standard abutments, this system is intended for submerged placement during the osseointegration phase, meaning it is buried beneath the gum tissue to protect the implant site while healing occurs. This approach helps ensure stable integration before the final restoration is attached.

Is the KJ Submerged System intended for use in both the upper (maxilla) and lower (mandible) jaws, and how is it supplied?

Yes, the KJ Submerged System is cleared for use in both partially or fully edentulous mandibles (lower jaw) and maxillae (upper jaw). It is supplied as a combination product, meaning it includes components necessary for submerged placement during the osseointegration phase of dental implant therapy. The system is not pre-packaged with restorative materials but is designed to work with compatible crowns, overdentures, or other restorative solutions after healing.

What model number is associated with the solid abutment variant of the KJ Submerged System, and is this the only variant available?

The solid abutment variant of the KJ Submerged System is specified under the model number SDC25010S. While this model is documented in the FDA submission, the broader system may include additional variants or configurations not explicitly listed in the provided data. For precise details on available models, it is recommended to consult the manufacturer’s latest technical documentation or contact Kj Meditech Co., Ltd. directly.

How is the KJ Submerged System regulated in the U.S., and what does the product code DZE indicate about its classification?

The KJ Submerged System is regulated under the FDA’s 510(k) clearance process, specifically classified under the Dental advisory committee (DE) with the product code DZE. This classification indicates it falls under dental implant abutments and was determined to be substantially equivalent to a legally marketed predicate device. The clearance was granted as a traditional 510(k), meaning it underwent a standard review process without involving the Premarket Consultation and Clarification Program (PCCP).

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 SUBMERGED SYSTEM by KJ MEDITECH CO., LTD | FDA 510(k) Summary, A Leader in Dental Implant- We are KJ MEDITECH Co., Ltd., KJ SUBMERGED SYSTEM - Solid Abutment - BEUDAMED, PDF K103810 - KJ SUBMERGED SYSTEM - 510kdatabase.net, KJ SUBMERGED SYSTEM - Solid Abutment - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kj Meditech Co., Ltd.

Sources (1)

  • FDA 510(k) K103810 24 fields · synced Sep 19, 2026