Diamodent
- Primary DI
- D907AB8010
- Brand
- Diamodent
- Company
- DIAMODENT INC
- Model
- N/A
- Catalog number
- AB801
- Device description
- Compatible with: 4.3mm Regular Platform (RP) NobelReplace implants Temporary Abutment, Titanium Non-Engaging, 1mm Collar, 5.3mm Profile
- Published
- 2019-01-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
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 |
|---|---|---|---|---|
| D907AB8010 | Primary | HIBCC | 0 |
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 |
|---|
| Dry Heat Sterilization |
Regulatory Flags
- DUNS number
- 013827410
- 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
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D907BV9101 | DiamoDent | N/A | BV910 | 2023-10-27 |
| D907BW9101 | DiamoDent | N/A | BW910 | 2023-10-27 |
| D907AA7550 | DiamoDent | N/A | AA755 | 2023-08-16 |
| D907AB7050 | DiamoDent | N/A | AB705 | 2023-08-16 |
| D907AB7550 | DiamoDent | N/A | AB755 | 2023-08-16 |
| D907AP10100 | DiamoDent | N/A | AP1010 | 2023-08-16 |
| D907AS10100 | DiamoDent | N/A | AS1010 | 2023-08-16 |
| D907AS10110 | DiamoDent | N/A | AS1011 | 2023-08-16 |
| D907T53200 | DiamoDent | N/A | T5320-6 | 2023-08-16 |
| D907T54910 | DiamoDent | N/A | T5491 | 2023-08-16 |
| D907T54930 | DiamoDent | N/A | T5493 | 2023-08-16 |
| D907BB9101 | DiamoDent | N/A | BB910 | 2022-04-15 |
| D907BC9101 | DiamoDent | N/A | BC910 | 2022-04-15 |
| D907BD9101 | DiamoDent | N/A | BD910 | 2022-04-15 |
| D907AJ10100 | DiamoDent | N/A | AJ1010 | 2022-04-14 |
| D907AJ10110 | DiamoDent | N/A | AJ1011 | 2022-04-14 |
| D907AJ8000 | DiamoDent | N/A | AJ800 | 2022-04-14 |
| D907AJ8010 | DiamoDent | N/A | AJ801 | 2022-04-14 |
| D907BA9000 | DiamoDent | N/A | BA900 | 2022-04-14 |
| D907AJ1000 | DiamoDent | N/A | AJ100 | 2022-04-13 |
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| 08800096850792 | 8plant Implant System | 8dent Inc. | DZE | 2026-03-24 |
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