Identity
- Trade Name
- Ionolux FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Ionolux EUDAMEDLight-curing glass ionomer restorativ material. FDA UDI
- Model / Reference
- 1990 EUDAMEDFDA UDI
- Description
- Light-curing glass ionomer restorativ material. FDA UDI
Identifiers
- Catalog Number
- 1990 FDA UDI
- Primary DI / UDI-DI
- E22119901 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E221023000000000078 EUDAMED
- 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
Yes
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
Ionolux by VOCO GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E221023000000000078 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (2)
- EUDAMED cc94d9e0-4c0f-443f-b566-10212871136d 61 fields · synced May 30, 2026
- FDA UDI c957bd82-de66-4e90-9c2a-30e77b8d10a7 36 fields · synced May 30, 2026