Zical Ultra Automix Paste
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Zical Ultra EUDAMEDZical Ultra Automix Paste FDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Device Name
- Sealers EUDAMED
- Model / Reference
- Sealers EUDAMED40043 EUDAMED15g FDA UDI
Identifiers
- Catalog Number
- 40043 FDA UDI
- Primary DI / UDI-DI
- +D9674004301 EUDAMEDD9674004301 FDA UDI
- Basic UDI-DI
- ++D967ESTF015L EUDAMED
- 510(k) Number
- K212563 FDA UDI
- FDA Product Code
- KIF FDA UDI
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
- GMDN Term
- Calcium hydroxide dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Market of Registration
- Cyprus EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Calcium hydroxide dental cement
Zical Ultra Automix Paste by Prevest Denpro Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K212563 also covers:
- ApexPaste I — Dsi Dental Solutions, Ltd.
- ApexSil Cal — Dsi Dental Solutions, Ltd.
- ApexSil RC — Dsi Dental Solutions, Ltd.
- ApexSil SIlver — Dsi Dental Solutions, Ltd.
- ReMTA One — Dsi Dental Solutions, Ltd.
- Zoer RC Automix — Dsi Dental Solutions, Ltd.
- CalApex — PREVEST DENPRO LIMITED
- CalApex — PREVEST DENPRO LIMITED
- CalApex Automix Paste — PREVEST DENPRO LIMITED
- CalApex Manual Mix Paste — PREVEST DENPRO LIMITED
- CalApex Manual Mix Paste — PREVEST DENPRO LIMITED
- Calplus — PREVEST DENPRO LIMITED
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prevest Denpro Limited
Sources (2)
- FDA UDI 0c68888e-ec40-4339-b818-e31d0e5a090f 34 fields · synced Jul 12, 2026
- EUDAMED b4fc6fa0-d324-4548-9f0b-71ae24a64c9b 61 fields · synced Jul 12, 2026