Identity
- Trade Name
- Sterngold 1 Type ll Yellow Crown & Bridge Alloy FDA UDI
- Generic Name
- Dental casting noble alloy FDA UDI
- Device Name
- High Noble, Type II Premium alloy with excellent gold color. Micro-fine grain. Harder than Sterngold S, it is better suited for MOD inlays. Casts into a highly aesthetic inlay and burnishes well. FDA UDI
- Model / Reference
- 1127781 FDA UDI
- Description
- High Noble, Type II Premium alloy with excellent gold color. Micro-fine grain. Harder than Sterngold S, it is better suited for MOD inlays. Casts into a highly aesthetic inlay and burnishes well. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549100253 FDA UDI
- 510(k) Number
- K022252 FDA UDI
- FDA Product Code
- EJS FDA UDI
- GMDN Term
- Dental casting noble alloy FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3060 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterngold 1 Type ll Yellow Crown & Bridge Alloy by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 20632994-e72d-4495-bcef-f340804b0c2b 36 fields · synced May 30, 2026