BioHorizons
- Primary DI
- 00847236014582
- Brand
- BioHorizons
- Company
- BIOHORIZONS IMPLANT SYSTEMS, INC
- Model
- TP3EWHA3
- Device description
- 3.0mm Extra Wide Healing Abutment, 3mm Height
- Published
- 2019-04-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product 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 |
|---|---|---|---|---|
| 00847236014582 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00847236014582 | 00847236014582 | 847236014582 | 0847236014582 |
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. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 967279910
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00847236027797 | BioHorizons | CNTE0T | CNTE0T | 2026-02-26 |
| 00847236027803 | BioHorizons | CNTE2T | CNTE2T | 2026-02-26 |
| 00847236027810 | BioHorizons | CNTE3S | CNTE3S | 2026-02-26 |
| 00847236027827 | BioHorizons | CNTE3T | CNTE3T | 2026-02-26 |
| 00847236027834 | BioHorizons | CNTE4S | CNTE4S | 2026-02-26 |
| 00847236027841 | BioHorizons | CNTE4T | CNTE4T | 2026-02-26 |
| 00847236027858 | BioHorizons | CNTEA3 | CNTEA3 | 2026-02-26 |
| 00847236027865 | BioHorizons | CNTEA4 | CNTEA4 | 2026-02-26 |
| 00847236027872 | BioHorizons | CNTNA3 | CNTNA3 | 2026-02-26 |
| 00847236027889 | BioHorizons | CNTNA4 | CNTNA4 | 2026-02-26 |
| 00847236027896 | BioHorizons | CRTE3S | CRTE3S | 2026-02-26 |
| 00847236027902 | BioHorizons | CRTE3T | CRTE3T | 2026-02-26 |
| 00847236027919 | BioHorizons | CRTE4S | CRTE4S | 2026-02-26 |
| 00847236027926 | BioHorizons | CRTE4T | CRTE4T | 2026-02-26 |
| 00847236027933 | BioHorizons | CRTEA3 | CRTEA3 | 2026-02-26 |
| 00847236027940 | BioHorizons | CRTEA4 | CRTEA4 | 2026-02-26 |
| 00847236027957 | BioHorizons | CRTNA3 | CRTNA3 | 2026-02-26 |
| 00847236027964 | BioHorizons | CRTNA4 | CRTNA4 | 2026-02-26 |
| 00847236027421 | BioHorizons | PXMUPSD | PXMUPSD | 2025-06-12 |
| 00847236027438 | BioHorizons | PXMUPSD25 | PXMUPSD25 | 2025-06-12 |
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