Dio Uf Hsa Internal Sub-Merged Implant System

FDA UDI

Class II (US FDA UDI)

by DIO Corporation

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 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 452025N 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 452025N FDA UDI
Primary DI / UDI-DI: 08806195918043 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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Implantable

Yes

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Contains Latex

FDA UDI

Prescription Use

Yes

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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

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Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

The DIO UF HSA Internal Sub-Merged Implant System is a specially designed dental implant system for use in partial or full edentulous mandibles and maxillae, comprising a combination of dental implants, superstructures, instruments for prosthetics, and surgical instruments. It features a unique two-piece design with a threaded screw anchorage component implanted into bone and a retention component protruding through gingival tissues to support a dental prosthesis.

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 6a111410-8bdc-498c-ad67-1023cc1ed690 37 fields · synced Jun 29, 2026