FDA UDI
In Commercial Distribution
🇺🇸 United States
XiVE®
DI: 07392532212130
·
Model: 32252432
·
Dentsply Implants Manufacturing GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- XiVE®
- Primary DI
- 07392532212130
- Version / Model
- 32252432
- Catalog Number
- 25-2432
- Company Name
- Dentsply Implants Manufacturing GmbH
- Labeler DUNS
- 344038836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-18
- Public Version
- 1
- Public Version Date
- 2020-11-26
- Public Version Status
- New
- Public Device Record Key
- 008ea681-4396-49c9-8c45-e0434e7417f8
Device Description
XiVE® TG plus Implant D3.4/L11
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55848 | Screw endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07392532212130 | GS1 | ||||
| Previous | EFRI322524322 | HIBCC |
Customer Contacts
- Phone
- +1(800)531-3481
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage, in the original packaging, at room temperature in a dry place away from sunlight.