UF(II) Implant System

FDA UDI

Class II (US FDA UDI)

by DIO Corporation

Identity

Trade Name: UF(II) Implant System FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Model / Reference: SSCA 45307N(II) FDA UDI

Identifiers

Catalog Number: SSCA 45307N(II) FDA UDI
Primary DI / UDI-DI: 08800049425046 FDA UDI
510(k) Number: K170608 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure, permanent, preformed

The UF(II) Implant System is a prefabricated dental implant suprastructure designed to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration. Made from various materials such as titanium (Ti), plastic, or gold alloy, it features one or more structural components that can be glued to prostheses or replaced during cleaning cycles.

SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
Diamodent — Diamodent · Class II
Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
GS System — OSSTEM IMPLANT Co., Ltd. · Class II
Temporary Abutment — Cybermed Inc. · Class II
EZ Post — Megagen Implant Co. Ltd · Class II

Cleared under the same submission

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: DIO Corporation

Sources (1)

FDA UDI 83f2eb73-5d71-465d-9bb2-fe3153ae24e7 35 fields · synced Jul 30, 2026

UF(II) Implant System

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)