DIO PROTEM IMPLANT SYSTEM
- Primary DI
- 08800049214749
- Brand
- DIO PROTEM IMPLANT SYSTEM
- Company
- DIO Corporation
- Model
- MFP 25410
- Catalog number
- MFP 25410
- Device description
- DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments.The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion offixture.The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
- Published
- 2022-03-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| DZE | Implant, Endosseous, Root-Form |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K080126 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800049214749 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800049214749 | 08800049214749 | 8800049214749 |
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 |
|---|
Contacts#
| Phone | |
|---|---|
| 213-365-2875 | usahq@dioimplantusa.com |
Regulatory Flags#
- DUNS number
- 631085206
- Device count
- 1
- DM exempt
- true
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- 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 | |
| 08800049282892 | Pre-milled Bar | CBMC 02H | 2025-09-16 | |
| 08800049282908 | Pre-milled Bar | CBMC 02N | 2025-09-16 | |
| 08800049283448 | Pre-milled Bar | CBZN 01 | 2025-09-16 |
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