Hero II Dental Implant System, Ui Dental Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130221 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 Hero II Dental Implant System and the UI Dental Implant System are endosseous dental implants designed for use in partially or fully edentulous mandibles and maxillae. These systems provide support for single or multiple-unit restorations, including cemented retained, screw retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework.
This device is identified under FDA 510(k) clearance K130221 and is classified as a Class 2 medical device. It has been determined to be substantially equivalent for its intended use in dental applications. Users should refer to the manufacturer's specific clinical guidelines for surgical protocols and compatibility requirements.
Frequently asked questions
What is the intended use of the Hero II and UI Dental Implant System?
These endosseous dental implants are designed for use in partially or fully edentulous mandibles and maxillae. They provide support for various restorations, including cemented or screw-retained units, overdentures, and terminal or intermediate abutments for fixed bridgework.
What is the regulatory status of these dental implant systems?
The Hero II and UI Dental Implant System are classified as Class 2 medical devices and have received FDA 510(k) clearance under K130221. The device has been determined to be substantially equivalent for its intended use in dental applications.
How should clinicians determine surgical protocols for these implants?
Clinicians should refer to the specific clinical guidelines provided by the manufacturer, Medimecca Co., Ltd. These documents contain the necessary surgical protocols and compatibility requirements to ensure the proper application of the implant systems.
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: Hero Ii Dental Implant System, Ui Dental Implant System, HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM by MEDIMECCA CO ..., Hero Ii Dental Implant System, Ui Dental Implant System, Hero Ii Dental Implant System, Ui Dental Implant System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130221 | Class II | Active |
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Manufacturer
- Manufacturer
- Medimecca Co., Ltd.
Sources (1)
- FDA 510(k) K130221 24 fields · synced Sep 22, 2026