Identity
- Trade Name
- ZCem Carb - Zinc Polycarb Cem 90g/30ml EUDAMEDZCEM Carb FDA UDI
- Generic Name
- Zinc polycarboxylate dental cement FDA UDI
- Device Name
- GI Luting cement / Zinc Polycarboxylate cement EUDAMEDZinc Polycarb Cement 90g/30ml FDA UDI
- Model / Reference
- AH0700 EUDAMEDFDA UDI
- Description
- Zinc Polycarb Cement 90g/30ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060446602874 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056009120268SX EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
- GMDN Term
- Zinc polycarboxylate dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Malta 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
Yes
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: Zinc polycarboxylate dental cement
ZCEM Carb by Advanced Healthcare Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Zinc polycarboxylate dental cement.
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- Durelon™ — 3M Deutschland GmbH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
Sources (2)
- FDA UDI 62caa218-3efb-4605-9dfd-a2b06593a181 34 fields · synced Jun 19, 2026
- EUDAMED 9cfb35da-48b6-4c50-be66-0131235d4585 61 fields · synced Jun 19, 2026