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Calcimol LC
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1047Ref 1097Model tube
by VOCO GmbH
Identity
- Trade Name
- Calcimol EUDAMEDFDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Device Name
- Calcimol LC EUDAMEDCalcimol EUDAMEDSelf-curing radiopaque calcium hydroxide paste. FDA UDI
- Model / Reference
- 1047 EUDAMED1097 EUDAMEDFDA UDItube EUDAMED
- Description
- Self-curing radiopaque calcium hydroxide paste. FDA UDI
Identifiers
- Catalog Number
- 1097 FDA UDI
- Primary DI / UDI-DI
- E22110471 EUDAMEDE22110971 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210640000000000CT EUDAMEDB-E22110971 EUDAMED
- FDA Product Code
- EJK FDA UDI
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS EUDAMEDQ01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
- GMDN Term
- Calcium hydroxide dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3250 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
Calcimol LC by VOCO GmbH — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | ++E2210640000000000CT | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K924182 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K923849 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210640000000000CT | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (4)
- EUDAMED 22481656-e9c9-4d4b-9130-fa8794c52d24 61 fields · synced Oct 6, 2026
- FDA UDI 58d6f42e-721d-423b-adef-732c70d04b2b 36 fields · synced May 30, 2026
- EUDAMED 2cba35ec-5abc-4c4f-a68f-fd95fb48cf51 61 fields · synced Jul 11, 2026
- FDA 510(k) K924182 1 fields · synced May 18, 2026