Identity
- Trade Name
- Galaxy White Ceramic Alloy FDA UDI
- Generic Name
- Dental casting noble alloy FDA UDI
- Device Name
- High Noble. Silver free gold-palladium dental alloy eliminates "greening" effect with its composition. Galaxy is compatible with most major porcelains. However, like most silverless white metals, there may be a potential for checking when used with porcelains possessing an exceptionally high-coefficients of expansion. FDA UDI
- Model / Reference
- 1065225 FDA UDI
- Description
- High Noble. Silver free gold-palladium dental alloy eliminates "greening" effect with its composition. Galaxy is compatible with most major porcelains. However, like most silverless white metals, there may be a potential for checking when used with porcelains possessing an exceptionally high-coefficients of expansion. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549100062 FDA UDI
- 510(k) Number
- K003007 FDA UDI
- FDA Product Code
- EJT 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
Galaxy White Ceramic 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 |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI f2aa8ae7-bdbb-4f6d-a2cc-f13d6c75505c 36 fields · synced Jun 1, 2026