Identity
- Trade Name
- HY-Temporary Soft FDA UDI
- Generic Name
- Zinc polycarboxylate dental cement FDA UDI
- Device Name
- HY-BOND POLY TEMP CEM 60/30 FDA UDI
- Model / Reference
- 1176 FDA UDI
- Description
- HY-BOND POLY TEMP CEM 60/30 FDA UDI
Identifiers
- Catalog Number
- 1176 FDA UDI
- Primary DI / UDI-DI
- E23511760 FDA UDI
- 510(k) Number
- K002461 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Zinc polycarboxylate dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
HY-Temporary Soft by Shofu Dental Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K002461 also covers:
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
- Shofu Dental Corp.
Sources (1)
- FDA UDI c0df61d4-8106-4cc2-b891-30438d729239 37 fields · synced May 30, 2026