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Glass Ionomer Cement
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref N/AModel Luting I, LuFill HS510(k) K161851Ref LuFill HS/A2/Powder: 30g; Liquid: 25g (21ml)Ref Luting I/Powder: 30g; Liquid: 25g
Identity
- Trade Name
- Glass Ionomer Cement (Luting) FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Glass Ionomer Cement EUDAMED
- Model / Reference
- Luting I, LuFill HS EUDAMEDN/A EUDAMEDLuFill HS/A2/Powder: 30g; Liquid: 25g (21ml) EUDAMEDLuting I/Powder: 30g; Liquid: 25g EUDAMEDLuting I, Luting II FDA UDI
Identifiers
- Catalog Number
- Powder: 30g; Liquid: 25g FDA UDI
- Primary DI / UDI-DI
- 06970402670252 EUDAMEDFDA UDI06909412311022 EUDAMED
- Basic UDI-DI
- 6909412GIC2A01M5 EUDAMED
- 510(k) Number
- K161851 FDA UDI
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 by Shandong Huge Dental Material Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Also classified as Glass ionomer dental cement.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160345 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K161851 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6909412GIC2A01M5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Huge Dental Material Corporation
- EUDAMED SRN
- CN-MF-000013266
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (7)
- EUDAMED b7d4a212-3013-4813-bc27-14c205d7e871 85 fields · synced Oct 6, 2026
- FDA UDI 5a965a17-5393-40d9-a464-3f302cff23e3 34 fields · synced May 29, 2026
- EUDAMED ed043c55-f725-4d26-b4a9-56d6befd383a-1 61 fields · synced Jul 8, 2026
- EUDAMED ed043c55-f725-4d26-b4a9-56d6befd383a-2 61 fields · synced Jul 8, 2026
- EUDAMED e3950349-479c-4f96-8cb1-743c14d5fc2f-1 61 fields · synced Oct 5, 2026
- EUDAMED e3950349-479c-4f96-8cb1-743c14d5fc2f-2 61 fields · synced Oct 5, 2026
- FDA 510(k) K160345 1 fields · synced May 18, 2026