DIO BIOTITE-H IMPLANT SYSTEMS
- Primary DI
- 08800049287286
- Brand
- DIO BIOTITE-H IMPLANT SYSTEMS
- Company
- DIO Corporation
- Model
- SSC 2008H
- Catalog number
- SSC 2008H
- Device description
- The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
- 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
dioimplantusa.comProduct 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 |
|---|---|---|---|---|
| 08800049287286 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800049287286 | 08800049287286 | 8800049287286 |
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 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07290120481039 | IH Straight Shoulder Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120481237 | IH Straight Shoulder Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120481435 | IH Straight Shoulder Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120482470 | IH Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120482524 | IH Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120482579 | IH Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120482623 | IH Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120482678 | IH Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120486621 | NP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120486676 | NP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120486720 | NP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120486775 | NP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120486829 | NP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120486874 | RP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120486928 | RP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120486973 | RP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487024 | RP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487079 | RP Straight Multi-Unit Abutment | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487383 | NP Straight Anatomic Abutment 3.0mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487437 | RP Straight Anatomic Abutment 5.0mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487482 | RP Straight Anatomic Abutment 5.0mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487529 | IH Straight Curve Concave Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487536 | NP Straight Anatomic Abutment 3.0mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487628 | IH Straight Curve Concave Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487727 | IH Straight Curve Concave Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120487826 | IH Straight Curve Concave Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120488328 | IH Straight Anatomic Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120488427 | IH Straight Anatomic Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120488526 | IH Straight Anatomic Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |
| 07290120488625 | IH Straight Anatomic Abutment 3.75mm diameter | SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD | NHA | 2026-03-24 |