Identity
- Trade Name
- Ionolux EUDAMEDFDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Ionolux EUDAMEDLight-curing glass ionomer restorativ material. FDA UDI
- Model / Reference
- 1991 EUDAMEDFDA UDI
- Description
- Light-curing glass ionomer restorativ material. FDA UDI
Identifiers
- Catalog Number
- 1991 FDA UDI
- Primary DI / UDI-DI
- E22119911 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
Ionolux by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- VOCO GmbH
Sources (2)
- FDA UDI ccce16af-9b2d-409e-a99e-5763e2623c6b 36 fields · synced Oct 7, 2026
- EUDAMED 7a1522da-8e69-4a5c-93d7-0f63a3ab1b0d 61 fields · synced Jul 15, 2026