Identity
- Trade Name
- System Soft-Blank 98,3 x 24,5 mm FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- Cobalt based dental milling alloy, type 4, Dimension: 98,3 x 24,5 mm FDA UDI
- Model / Reference
- 2024 FDA UDI
- Description
- Cobalt based dental milling alloy, type 4, Dimension: 98,3 x 24,5 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- EADT20241 FDA UDI
- FDA Product Code
- EJH FDA UDI
- GMDN Term
- Dental casting non-noble alloy FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Dental casting non-noble alloy
System Soft-Blank 98, 3 x 24, 5 mm by Adentatec GmbH Competence in Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Adentatec GmbH Competence in Dental
Sources (1)
- FDA UDI 032ca744-01fa-427f-b8ea-f0b7c30ce8bf 33 fields · synced May 30, 2026