Identity
- Trade Name
- Glass Ionomer Cement (Luting) FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Model / Reference
- Luting I, Luting II FDA UDI
Identifiers
- Catalog Number
- Powder: 10g; Liquid: 10g FDA UDI
- Primary DI / UDI-DI
- 06970402670276 FDA UDI
- 510(k) Number
- K161851 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- 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
Category: Glass ionomer dental cement
Glass Ionomer Cement (Luting) by Shandong Huge Dental Material Corporation — 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
- Shandong Huge Dental Material Corporation
Sources (1)
- FDA UDI 0a9dafd1-0e1e-45f1-8a99-6cda9ca3be0f 34 fields · synced May 30, 2026