FDA UDI
In Commercial Distribution
🇺🇸 United States
Vertex-Dental BV
DI: 08719425508955
·
Model: NDCMN1.501000_1
·
Vertex-Dental B.V.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vertex-Dental BV
- Primary DI
- 08719425508955
- Version / Model
- NDCMN1.501000_1
- Company Name
- Vertex-Dental B.V.
- Labeler DUNS
- 406389056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-03
- Public Version
- 1
- Public Version Date
- 2023-08-11
- Public Version Status
- New
- Public Device Record Key
- 448ba068-3577-451e-a1c2-8fb17dc7b7d3
Device Description
For manufacturing 3d printed crowns and bridges
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELJ | TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT | Dental | 872.3900 | 1 |
| ELK | TEETH, ARTIFICIAL, BACKING AND FACING | Dental | 872.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45236 | Temporary dental crown/bridge resin | A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719425508955 | GS1 |