Identifiers
- 510(k) Number
- K090237 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 Hg Ii Fixture System is a dental implant system designed for use in partially or fully edentulous mandibles and maxillae. It provides 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 number K090237. It is manufactured by Hiossen, Inc. and is categorized under the dental advisory committee.
Frequently asked questions
What is the intended use of the Hg II Fixture System?
The Hg II Fixture System is designed for use in partially or fully edentulous mandibles and maxillae. It provides the necessary support for various dental restorations, including single or multiple-unit cemented or screw-retained restorations, overdentures, and fixed bridgework.
What regulatory documentation is associated with this device?
The Hg II Fixture System is cleared for use under FDA 510(k) number K090237. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the Hg II Fixture System?
The Hg II Fixture System is manufactured by Hiossen, Inc., located in Fairless Hills, Pennsylvania. The company is the applicant responsible for the device's regulatory filing under the dental advisory committee.
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: HG II FIXTURE SYSTEM by HIOSSEN INC. | FDA 510 (k) Summary, HG II FIXTURE SYSTEM (K090237) — FDA 510 (k) | Innolitics, HG II FIXTURE SYSTEM (K080744) — FDA 510 (k) | Innolitics, Dental Implant Systems, Equipment & Education | Hiossen
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090237 | Class II | Active |
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Manufacturer
- Manufacturer
- Hiossen, Inc.
Sources (1)
- FDA 510(k) K090237 24 fields · synced Sep 25, 2026