CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Calapex EUDAMED
- Device Name
- Sealers EUDAMED
- Model / Reference
- Sealers EUDAMED40065 EUDAMED40041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D9674006505 EUDAMED+D967400410% EUDAMED
- Basic UDI-DI
- ++D967ESTF015L EUDAMED
- 510(k) Number
- K212563 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Market of Registration
- Bulgaria EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
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
These dental materials are resin-based root canal filling systems designed for obturation of the root canal system. They provide a radiopaque seal to prevent microbial leakage and promote long-term periapical healing by filling voids and irregularities within the canal space.
The systems are supplied as paste, powder/liquid combinations, or ready-mixed formulations for single-use applications in endodontic procedures. Authorized under FDA 510K and MDR compliance, they are classified as Class II devices and intended for use in dental offices. Sterility and precise mixing ratios are critical for proper application, with each variant adhering to specific storage and handling guidelines as outlined in the manufacturer’s instructions.
Frequently asked questions
Are these materials reusable or designed for single-use in endodontic procedures?
These dental materials—CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, and Zical Ultra Powder/Liquid—are explicitly supplied as single-use formulations for endodontic obturation. The manufacturer emphasizes that sterility and precise mixing ratios are critical for proper application, which aligns with single-use design principles to ensure consistency and safety per their instructions.
How should I store these products to maintain their integrity before use?
Storage guidelines are outlined in the manufacturer’s instructions, but the key requirement is adherence to sterility and handling protocols for resin-based root canal filling systems. Since these are single-use, they must be stored in a clean, dry environment (as per standard dental material storage practices) and protected from contamination, moisture, or extreme temperatures. Always follow the specific storage conditions detailed in the accompanying packaging or instructions.
What regulatory pathways have these products undergone, and how does that affect their use in dental offices?
These materials are authorized under FDA 510K clearance and MDR compliance, classifying them as Class II devices. This means they’ve undergone rigorous review by regulatory bodies to demonstrate safety and effectiveness for their intended use in dental offices. Clinicians can rely on these pathways to confirm the products meet established standards for root canal obturation, though local regulations may still apply.
Are there different formulations (e.g., paste vs. powder/liquid) that require specific handling or mixing steps?
Yes, the systems vary by formulation: paste variants (like Zical Ultra Paste) are ready-to-use, while others (e.g., Zical Ultra Powder/Liquid) require precise mixing per the manufacturer’s instructions. The Nanoseal S and Cerafill RCS are also designed for specific mixing ratios to achieve optimal radiopacity and sealing properties. Always refer to the product-specific instructions to avoid errors in application, as improper mixing can compromise the seal and periapical healing outcomes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212563 | Class II | Active |
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Manufacturer
- Manufacturer
- Prevest Denpro Limited
Sources (3)
- FDA 510(k) K212563 24 fields · synced Oct 6, 2026
- EUDAMED 9f634e91-e7ba-4c71-80c0-7764df2be2fe 61 fields · synced Jul 11, 2026
- EUDAMED f792bbfd-5dd2-4807-b9eb-b02f93f7fbc2 61 fields · synced Jul 11, 2026