Identity
- Trade Name
- Platinum Foil 1 DWT FDA UDI
- Generic Name
- Dental casting noble alloy FDA UDI
- Device Name
- 92mm x 32mm x .02 mm thick. Dental metal foil for the preparation of dental appliances. FDA UDI
- Model / Reference
- 1420001 FDA UDI
- Description
- 92mm x 32mm x .02 mm thick. Dental metal foil for the preparation of dental appliances. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549118289 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Platinum Foil 1 DWT 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 9111cc8d-6b58-4b3d-b4d5-e6dce6e2ff68 35 fields · synced May 30, 2026