FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Omega (1 Kilo)-Type IV BE Free Non-Precious Ceramic Alloy
DI: 00841549100536
·
Model: 5012238
·
STERNGOLD DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Omega (1 Kilo)-Type IV BE Free Non-Precious Ceramic Alloy
- Primary DI
- 00841549100536
- Version / Model
- 5012238
- Company Name
- STERNGOLD DENTAL LLC
- Labeler DUNS
- 124763728
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-02
- Public Version
- 2
- Public Version Date
- 2023-10-09
- Public Version Status
- Update
- Public Device Record Key
- 1fd32667-9b68-4700-8463-0972c96b6c6f
- Distribution End Date
- 2023-10-06
Device Description
Non-precious Ceramic Alloy
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 |
|---|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | Dental | 872.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35858 | Dental casting noble alloy | A material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. 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 | 00841549100536 | GS1 |
Customer Contacts
- Phone
- 5082265660
- [email protected]