Identifiers
- 510(k) Number
- K101096 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 HT III SA Fixture System is an implant, endosseous, root-form device classified under product code DZE. It features a sand-blasted and acid-etched (SA) surface with an internal hex connection. This system is designed for dental implant procedures.
The HT III SA Fixture System is manufactured by Hiossen, Inc. and received FDA 510(k) clearance on October 8, 2010. It is supplied as a Class II device with special controls. The system is manufactured and packaged in Pennsylvania, USA.
Frequently asked questions
What is the HT III SA Fixture System used for?
The HT III SA Fixture System is an implant, endosseous, root-form device designed specifically for dental implant procedures. It features a sand-blasted and acid-etched surface with an internal hex connection to facilitate secure placement in the jawbone.
How is the HT III SA Fixture System supplied?
The system is supplied as a Class II device with special controls. It is manufactured and packaged in Pennsylvania, USA by Hiossen, Inc. Each unit is designed for dental implant procedures and comes with the necessary specifications for professional use.
What is the regulatory status of the HT III SA Fixture System?
The HT III SA Fixture System received FDA 510(k) clearance on October 8, 2010, with decision code SESE (Substantially Equivalent). It is classified under product code DZE and was reviewed by the Dental advisory committee (DE).
What are the key features of the HT III SA Fixture System?
The HT III SA Fixture System features a sand-blasted and acid-etched (SA) surface that promotes osseointegration, and an internal hex connection for stability during and after implantation. These design elements are intended to enhance the success rate of dental implant procedures.
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: K101096 FDA 510(k) - HT III SA FIXTURE SYSTEM | Hiossen, Inc., Dental Implant Systems, Equipment & Education | Hiossen, ET III SA Regular Implant - eshop.hiossen.com, PDF Hiossen Implant Solution
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101096 | Class II | Active |
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Manufacturer
- Manufacturer
- Hiossen, Inc.
Sources (1)
- FDA 510(k) K101096 24 fields · synced Sep 25, 2026