Identity
- Trade Name
- DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- The DIO UF HSA Internal Sub-Merged Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surery. A successfully osseointegrated implant willl achieve a firm implant when the fixture is operated under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edendulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist of screws(Cover Screw, Coping Screw), abutments(Screw retained type, Cemented retained type, Over denture retained type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F67) and Ti-6A1-4VELI(ASTM F136) intended to be used in a narrow tooth gap after implant insertion. And the screw is used to protect exposed top of the implant or to attach the abutment to implant. FDA UDI
- Model / Reference
- SSMA 5525N FDA UDI
- Description
- The DIO UF HSA Internal Sub-Merged Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surery. A successfully osseointegrated implant willl achieve a firm implant when the fixture is operated under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edendulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist of screws(Cover Screw, Coping Screw), abutments(Screw retained type, Cemented retained type, Over denture retained type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F67) and Ti-6A1-4VELI(ASTM F136) intended to be used in a narrow tooth gap after implant insertion. And the screw is used to protect exposed top of the implant or to attach the abutment to implant. FDA UDI
Identifiers
- Catalog Number
- SSMA 5525N FDA UDI
- Primary DI / UDI-DI
- 08806195918685 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dio Uf Hsa Internal Sub-Merged Implant System by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DIO Corporation
Sources (1)
- FDA UDI 7851f930-0a1e-4191-bb66-260681948c22 37 fields · synced May 31, 2026