Diamodent
- Primary DI
- D907AE6501
- Brand
- Diamodent
- Company
- DIAMODENT INC
- Model
- N/A
- Catalog number
- AE650
- Device description
- Compatible with: 3.4mm Frialit-2 & XiVE Friadent implants ComScrew, Titanium 1.2mm (0.48") Hex 20 Ncm
- 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
- true
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 |
|---|---|---|---|---|
| D907AE6501 | Package | HIBCC | 6 | In Commercial Distribution |
| D907AE6500 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental prosthesis/implant abutment screw | A non-sterile device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device intended to be sterilized prior to use. |
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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