FDA UDI
In Commercial Distribution
🇺🇸 United States
Vertex-Dental BV
DI: 08719425508634
·
Model: NDTRPI01000
·
Vertex-Dental B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vertex-Dental BV
- Primary DI
- 08719425508634
- Version / Model
- NDTRPI01000
- Company Name
- Vertex-Dental B.V.
- Labeler DUNS
- 406389056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-11
- Public Version
- 1
- Public Version Date
- 2018-11-12
- Public Version Status
- New
- Public Device Record Key
- fe2fc289-1f15-4828-ba25-5f6f7b155ab7
Device Description
3D printing material for try-in devices
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
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EEA | PLATE, BASE, SHELLAC | Dental | 872.6200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61648 | Dental prosthesis bite verification device | A device intended to aid in the fabrication of a dental prosthesis (e.g., crown, bridge) by connecting the try-in prosthesis to the laboratory working model and to the patient for the purpose of verifying the fit and appearance of the final prosthesis before production. It is affixed with a dental prosthetic screw or dental prosthetic screw analogu(also known as guide pin). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719425508634 | GS1 |