DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM

Primary DI
08806195919682
Brand
DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
Company
DIO Corporation
Model
SSOA 6545
Catalog number
SSOA 6545
Device 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.
Published
2016-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806195919682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806195919682088061959196828806195919682

GMDN Terms

TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
213-365-2875usahq@dioimplantusa.com

Regulatory Flags

DUNS number
631085206
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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08800049245330Healing CapHCI 48504[H]2025-09-19
08800049245361Healing CapHCI 65704[H]2025-09-19
08800049245422Cemented CylinderICC 48508[H]2025-09-19
08800049245460Cemented CylinderICC 48588[H]2025-09-19
08800049245507Cemented CylinderICC 60649[H]2025-09-19
08800049245545Cemented CylinderICC 65309[H]2025-09-19
08800049416884Temporary CylinderITC 480102025-09-19
08806169097729Healing CapHCI 60704[H]2025-09-19
08800049414217DIOnavi GuideGUIDE 02 A01(a,b)2025-09-18
08800049414231DIOnavi GuideGUIDE 02 A02(a,b)2025-09-18
08800049414255DIOnavi GuideGUIDE 02 A03(a,b)2025-09-18
08800049414279DIOnavi GuideGUIDE 02 A04(a,b)2025-09-18
08800049414293DIOnavi GuideGUIDE 02 A05(a,b)2025-09-18
08800049438961UF(II) Eastab CylinderESMC 4812N2025-09-18
08800049438985UF(II) Eastab CylinderESMC 4812H2025-09-18
08800049438992UF(II) Eastab Cylinder Semi FinalESMCSF 4806N2025-09-18
08800049443040UF(II) Eastab Cylinder Semi FinalESMCSF 4806H2025-09-18
08800049233948Extension Cemented AbutmentAEI 48007N[H]2025-09-15
08800049234006Extension Cemented AbutmentAEI 48017[H]2025-09-15
08800049234020Extension Cemented AbutmentAEI 48017N[H]2025-09-15

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