UFIII Fixture
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- UFIII Fixture EUDAMEDFDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- UFIII Narrow Fixture, UFIII Fixture EUDAMED
- Model / Reference
- UFIIIN 3008S EUDAMEDDIO Implant System Product Catalog Ver 7.0 (KR) EUDAMEDUFIIIN 3008SF EUDAMEDUFIII 3811S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800049479414 EUDAMED08800049482872 EUDAMED08800049452615 FDA UDI
- Basic UDI-DI
- 880004925003B4 EUDAMED880004921001A4 EUDAMED
- 510(k) Number
- K122519 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Screw endosteal dental implant, two-piece
UFIII Fixture by DIO Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
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
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DIO Corporation
Sources (3)
- FDA UDI 53d980fd-9da8-47b4-90d3-4b08a151fdd3 35 fields · synced Jul 8, 2026
- EUDAMED d975de7c-6473-4811-bacd-34b6dd579f0f 61 fields · synced Jul 8, 2026
- EUDAMED 52b13a01-28c1-445a-b112-97cbdbd6a0d4 61 fields · synced Jul 8, 2026