Identity
- Trade Name
- Endoseal EUDAMEDFDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Device Name
- Sealers EUDAMED
- Model / Reference
- Sealers EUDAMED40031 EUDAMED15g powder FDA UDI
Identifiers
- Catalog Number
- 40031 FDA UDI
- Primary DI / UDI-DI
- +D967400310+ EUDAMEDD967400310 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
- Ireland 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 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
Yes
FDA UDI
Category: Calcium hydroxide dental cement
Endoseal 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prevest Denpro Limited
Sources (2)
- FDA UDI 7c142bcf-f14a-42e7-8ede-c3cd355176b0 34 fields · synced Jul 16, 2026
- EUDAMED 3877f63a-ac95-4a3e-b3fc-427670a0293b 61 fields · synced Jul 16, 2026