Identity
- Trade Name
- Calplus FDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Model / Reference
- Intro Pack FDA UDI
Identifiers
- Catalog Number
- 40005-1 FDA UDI
- Primary DI / UDI-DI
- D96740005A09 FDA UDI
- 510(k) Number
- K212563 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Calcium hydroxide dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI c00f28a1-c68d-4aa7-8e84-e7ac88dca696 34 fields · synced May 30, 2026