Dio Uf Hsa Internal Sub-Merged Implant System

FDA UDI

Class I (US FDA UDI)

by DIO Corporation

Identity

Trade Name: DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM FDA UDI
Generic Name: Dental implant analog 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: SSAA 7505 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: SSAA 7505 FDA UDI
Primary DI / UDI-DI: 08800049274354 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental implant analog FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant analog

Dio Uf Hsa Internal Sub-Merged Implant System by DIO Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant analog.

Digital Lab Analog Screw — DENTIS CO. , LTD · Class I
Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
One Stage TL S — I3 IMPLANT LLC · Class II
Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
Implant Analog 6mm Trilobe Stainless Steel — Sterngold Dental LLC · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: DIO Corporation

Sources (1)

FDA UDI 8ffd735d-d594-4d0b-90ea-519087ea3323 37 fields · synced May 31, 2026