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Calplus
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 40063Model SealersRef 40006Ref 40055
Identity
- Trade Name
- Calplus EUDAMEDFDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Device Name
- Sealers EUDAMED
- Model / Reference
- Sealers EUDAMED40063 EUDAMED40006 EUDAMED40055 EUDAMEDEconomy Pack FDA UDI
Identifiers
- Catalog Number
- 40006 FDA UDI
- Primary DI / UDI-DI
- +D9674006303 EUDAMED+D9674000600 EUDAMED+D9674005504 EUDAMEDD967400060 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
- Austria EUDAMEDGermany 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
Calplus by Prevest Denpro Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Calcium hydroxide dental cement.
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- Cerafill Putty — PREVEST DENPRO LIMITED · Class IIa
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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 (4)
- FDA UDI c0350e9d-8db5-40ba-bd97-0ec61f6eda4a 34 fields · synced Jul 21, 2026
- EUDAMED 96cff823-e1c0-4c7b-b300-4b799b7e3acd 61 fields · synced Jun 20, 2026
- EUDAMED bdb3a1a6-e0fe-4076-b67e-26ca9f91d359 61 fields · synced Jul 12, 2026
- EUDAMED 821288b5-89ea-4883-9215-277983c59d1f 61 fields · synced Jul 21, 2026