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UF Implant System

FDA UDI

Class II (US FDA UDI)

by DIO Corporation

Identity

Trade Name
UF 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. The Dental Implants, fixtures are made of commercial pure titanium, grade 4(ASTM F67) which have a S.L.A (Sand-blasted Large grit Acid-etched) treated surface. These fixtures can be used one-stage surgery method or two-stage surgery method. And that are surgically inserted into the upper and/or lower jaw bone. The fixtures replace tooth root as providing a stable foundation for restorations. The fixtures have the diameter(3.8 ~ 7.0mm)and length.(7 ~ 16mm) FDA UDI
Model / Reference
UF 4515S 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. The Dental Implants, fixtures are made of commercial pure titanium, grade 4(ASTM F67) which have a S.L.A (Sand-blasted Large grit Acid-etched) treated surface. These fixtures can be used one-stage surgery method or two-stage surgery method. And that are surgically inserted into the upper and/or lower jaw bone. The fixtures replace tooth root as providing a stable foundation for restorations. The fixtures have the diameter(3.8 ~ 7.0mm)and length.(7 ~ 16mm) FDA UDI

Identifiers

Catalog Number
UF 4515S FDA UDI
Primary DI / UDI-DI
18806195930042 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
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

UF Implant System by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K122519 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DIO Corporation

Sources (1)

  • FDA UDI e5004215-1047-4de8-be45-bd1241a2f108 39 fields · synced May 31, 2026