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Provicol QM Plus
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1098Ref 1074Ref 1099
by VOCO GmbH
Identity
- Trade Name
- Provicol QM Plus EUDAMEDFDA UDIProvicol QM EUDAMEDFDA UDI
- Generic Name
- Fatty acid dental cement FDA UDI
- Device Name
- Provicol QM Plus EUDAMEDProvicol EUDAMEDEugenol-free temporary luting cement with calcium hydroxide. FDA UDI
- Model / Reference
- 1098 EUDAMEDFDA UDI1099 EUDAMEDFDA UDI1074 EUDAMEDFDA UDI
- Description
- Eugenol-free temporary luting cement with calcium hydroxide. FDA UDI
Identifiers
- Catalog Number
- 1098 FDA UDI1099 FDA UDI1074 FDA UDI
- Primary DI / UDI-DI
- E22110981 EUDAMEDFDA UDIE22110991 EUDAMEDFDA UDIE22110741 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210360020000000CG EUDAMED++E2210360000000000BA EUDAMED
- 510(k) Number
- K161630 FDA UDI
- FDA Product Code
- EMB FDA UDIEMA FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Fatty acid dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDIClass 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
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
No
FDA UDI
Convenience Kit
No
FDA UDIFDA 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
Dimensions & Sizes
- Size
- Weight — 250 Gram FDA UDI
Provicol QM Plus by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161630 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210360020000000CG | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (7)
- EUDAMED 2f7b7bb5-5155-4fe7-b5df-8a33379d3082 61 fields · synced Oct 6, 2026
- FDA UDI bd2b22fc-2eb9-4836-98eb-f9b2f2c7f932 37 fields · synced May 30, 2026
- FDA UDI c6b4030b-7fdb-41b0-9324-1ebc846bc18d 35 fields · synced May 30, 2026
- FDA UDI f2cd234b-ce5a-4513-bc97-c92a9217f7e2 35 fields · synced May 30, 2026
- EUDAMED 0f9daafe-d098-4ea2-a500-8ce6b2ef2f25 61 fields · synced Jul 15, 2026
- EUDAMED 37e24755-fdad-48ed-b6e7-7377f40cc454 61 fields · synced Jul 17, 2026
- FDA 510(k) K161630 1 fields · synced May 18, 2026