FDA UDI
In Commercial Distribution
🇺🇸 United States
The Orthodontic Store
DI: 00843471101353
·
Model: 365-140
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- The Orthodontic Store
- Primary DI
- 00843471101353
- Version / Model
- 365-140
- Catalog Number
- 365-140
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 1
- Public Version Date
- 2022-12-02
- Public Version Status
- New
- Public Device Record Key
- 2463632c-86e2-43bd-8071-9e4e6a1f0c64
Device Description
SILVER SOLDER .040
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
- 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 |
|---|---|---|---|---|
| EJS | ALLOY, OTHER NOBLE METAL | Dental | 872.3060 | 2 |
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 |
|---|---|---|---|---|---|---|
| Package | 10843471101350 | GS1 | Inner | 1 | In Commercial Distribution | |
| Primary | 00843471101353 | GS1 |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]