EXTERNA® UNIVERSAL TEMPORARY BIOABUTMENT® Ø5 L:4 MM, NON-ROTATING
- Primary DI
- 08435389808145
- Brand
- EXTERNA® UNIVERSAL TEMPORARY BIOABUTMENT® Ø5 L:4 MM, NON-ROTATING
- Company
- BIOTECHNOLOGY INSTITUTE SL
- Model
- CPIUB14
- Published
- 2015-10-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| DZE | Implant, Endosseous, Root-Form |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08435389808145 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08435389808145 | 08435389808145 | 8435389808145 |
GMDN Terms
| Term | Definition |
|---|
| Dental implant suprastructure, temporary, preformed, single-use | A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 4 | Millimeter |
| Outer Diameter | 5 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| 2156464067 | christinebattilana@bti-implant.us |
Regulatory Flags
- DUNS number
- 461665312
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|
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| 08435389830320 | SHORT DRILL; Ø1.5 MM | F15CS | | 2026-01-30 |
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