Identity
- Trade Name
- Bio-H Type lV Yellow Crown & Bridge Alloy FDA UDI
- Generic Name
- Dental casting noble alloy FDA UDI
- Device Name
- High Noble. Type IV crown and bridge alloy. Bio-H is extra hard. When heat treated its Vickers value is 290. It also has good yield strength and can be used for bridges and removable partial denture frameworks. FDA UDI
- Model / Reference
- 1127006 FDA UDI
- Description
- High Noble. Type IV crown and bridge alloy. Bio-H is extra hard. When heat treated its Vickers value is 290. It also has good yield strength and can be used for bridges and removable partial denture frameworks. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549100239 FDA UDI
- 510(k) Number
- K962326 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
Bio-H Type lV 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 34a51b3e-4eac-4dee-b52d-e743ad002ff4 36 fields · synced May 30, 2026