DIO STEADY External Implant System
- Primary DI
- 18806195920487
- Brand
- DIO STEADY External Implant System
- Company
- DIO Corporation
- Model
- ETF 3710R
- Catalog number
- ETF 3710R
- Device description
- The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units` prosthetic appliance attachment to restore a patient`s chewing function. Implants can be placed with a conventional two stage surgical process with an option for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
- Published
- 2015-09-14
- Public version status
- Update
- Distribution status
- Not 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 |
|---|---|
| K100100 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 18806195920487 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 18806195920487 | 18806195920487 |
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 |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | tmperature limitation 1˚C ~ 30˚C, Humidity 80% |
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#
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|---|---|---|---|---|
| 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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