DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
- Primary DI
- 08800049281048
- Brand
- DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
- Company
- DIO Corporation
- Model
- SSTI 4010H
- Catalog number
- SSTI 4010H
- 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
- 2022-03-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| NHA | Abutment, Implant, Dental, Endosseous |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800049281048 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800049281048 | 08800049281048 | 8800049281048 |
GMDN Terms
| Term | Definition |
|---|---|
| Screw endosteal dental implant, two-piece | A 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
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 1 Degrees Celsius | 30 Degrees Celsius |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| 213-365-2875 | usahq@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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08800049245330 | Healing Cap | HCI 48504[H] | 2025-09-19 | |
| 08800049245361 | Healing Cap | HCI 65704[H] | 2025-09-19 | |
| 08800049245422 | Cemented Cylinder | ICC 48508[H] | 2025-09-19 | |
| 08800049245460 | Cemented Cylinder | ICC 48588[H] | 2025-09-19 | |
| 08800049245507 | Cemented Cylinder | ICC 60649[H] | 2025-09-19 | |
| 08800049245545 | Cemented Cylinder | ICC 65309[H] | 2025-09-19 | |
| 08800049416884 | Temporary Cylinder | ITC 48010 | 2025-09-19 | |
| 08806169097729 | Healing Cap | HCI 60704[H] | 2025-09-19 | |
| 08800049414217 | DIOnavi Guide | GUIDE 02 A01(a,b) | 2025-09-18 | |
| 08800049414231 | DIOnavi Guide | GUIDE 02 A02(a,b) | 2025-09-18 | |
| 08800049414255 | DIOnavi Guide | GUIDE 02 A03(a,b) | 2025-09-18 | |
| 08800049414279 | DIOnavi Guide | GUIDE 02 A04(a,b) | 2025-09-18 | |
| 08800049414293 | DIOnavi Guide | GUIDE 02 A05(a,b) | 2025-09-18 | |
| 08800049438961 | UF(II) Eastab Cylinder | ESMC 4812N | 2025-09-18 | |
| 08800049438985 | UF(II) Eastab Cylinder | ESMC 4812H | 2025-09-18 | |
| 08800049438992 | UF(II) Eastab Cylinder Semi Final | ESMCSF 4806N | 2025-09-18 | |
| 08800049443040 | UF(II) Eastab Cylinder Semi Final | ESMCSF 4806H | 2025-09-18 | |
| 08800049233948 | Extension Cemented Abutment | AEI 48007N[H] | 2025-09-15 | |
| 08800049234006 | Extension Cemented Abutment | AEI 48017[H] | 2025-09-15 | |
| 08800049234020 | Extension Cemented Abutment | AEI 48017N[H] | 2025-09-15 |
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