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 surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. FDA UDI
- Model / Reference
- UF(II) 5507S 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 surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. FDA UDI
Identifiers
- Catalog Number
- UF(II) 5507S FDA UDI
- Primary DI / UDI-DI
- 08800049226841 FDA UDI
- 510(k) Number
- K122519 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- 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
Category: Screw endosteal dental implant, two-piece
DIO UF HSA Internal Sub-Merged Implant System by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K122519 also covers:
- Cemented Cylinder — DIO Corporation
- DIO UF HSA Internal Sub-Merged Implant System — DIO Corporation
- DIO UF HSA Internal Sub-Merged Implant System — DIO Corporation
- DIO UF HSA Internal Sub-Merged Implant System — DIO Corporation
- DIO UF HSA Internal Sub-Merged Implant System — DIO Corporation
- DIO UF HSA Internal Sub-Merged Implant System — DIO Corporation
- Temporary Cylinder — DIO Corporation
- UFIII Fixture — DIO Corporation
- UFIII Fixture — DIO Corporation
- UFIII Fixture — DIO Corporation
- UFIII Fixture — DIO Corporation
- UFIII Fixture — DIO Corporation
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 e407764a-c5a8-4345-9ef6-cf4d18f20be7 38 fields · synced May 30, 2026