FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal Solder
DI: 07640159161295
·
Model: 10002
·
Produits dentaires S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Universal Solder
- Primary DI
- 07640159161295
- Version / Model
- 10002
- Company Name
- Produits dentaires S.A.
- Labeler DUNS
- 480420090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-15
- Public Version
- 1
- Public Version Date
- 2022-06-23
- Public Version Status
- New
- Public Device Record Key
- 57059cc3-2736-4491-bc9e-ce175e8ec31f
Device Description
Universal Dental - White Normal Quality - 6 sticks Universal Solder can be used to braze many metals or alloys to another metal or alloy as long as their melting points are not lower than 600 C It is intended for orthodontics, temporary appliances, repairs
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ECR | Setter, Band, Orthodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38779 | Dental soldering alloy | A mixture of metals in the form of a thin rod used to solder cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the soldering metal melts around the joint to create the fusion. The soldering process operates at lower termperatures than brazing. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640159161295 | GS1 |
Customer Contacts
- Phone
- +41219212631
- [email protected]