FDA UDI
In Commercial Distribution
🇺🇸 United States
Jensen Premium Dental Alloy
DI: 00817340021059
·
Model: Jensen Gold Foil (3g)
·
JENSEN INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jensen Premium Dental Alloy
- Primary DI
- 00817340021059
- Version / Model
- Jensen Gold Foil (3g)
- Catalog Number
- 5236Q
- Company Name
- JENSEN INDUSTRIES INC.
- Labeler DUNS
- 060018587
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 701df5e8-2599-4943-95ac-e1f6f98d98e5
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | Dental | 872.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11159 | Dental restorative gold | A dental restorative material made from gold (Au) foil, sintered gold (Au) powder, or a combination of both, for the preparation of gold tooth fillings directly in the mouth of a patient by condensing the material with a mallet and a plugger. The material is cold welded by this process. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817340021059 | GS1 |