Identity
- Trade Name
- Meron FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Meron EUDAMEDGlass ionomer luting cement. Low solubility in the mouth. Low acidity. Biocompatible. Easy application. FDA UDI
- Model / Reference
- 1086 EUDAMEDFDA UDI
- Description
- Glass ionomer luting cement. Low solubility in the mouth. Low acidity. Biocompatible. Easy application. FDA UDI
Identifiers
- Catalog Number
- 1086 FDA UDI
- Primary DI / UDI-DI
- E22110861 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E221024000000000087 EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS 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: Dental composite resin
Meron 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 | ++E221024000000000087 | 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 71cf651d-c1ae-4115-b0a5-071f2af06682 61 fields · synced Oct 6, 2026
- FDA UDI 896d2c4e-129d-4e6e-b553-6b82b7edebb3 36 fields · synced May 30, 2026