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Prevest Denpro Cavity Liners - Apacal ART

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K212475

by Prevest Denpro Limited

Identifiers

510(k) Number
K212475 FDA 510(k)
FDA Product Code
EJK FDA 510(k)
Models / Variants
Apacal ART FDA 510(k)EUDAMED
Cal LC FDA 510(k)EUDAMED
Calcigel FDA 510(k)EUDAMED
CalUltra FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3250 FDA 510(k)
Regulation Number
872.3250 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) are dental cavity liners classified as calcium hydroxide-based materials. These products serve as protective barriers between dental pulp and restorative materials, promoting pulp protection and aiding in pulp capping procedures. Apacal ART and Cal LC are light-cured pastes, while Calcigel is a ready-to-use calcium hydroxide paste, and CalUltra is a two-part base/catalyst system. They are designed to provide radiopacity and support dentine-pulp complex healing.

These cavity liners are supplied as single-use dental materials for use in clinical settings by dental professionals. Apacal ART and Cal LC are radiopaque, light-curable pastes, while Calcigel is a non-curing paste, and CalUltra requires mixing before application. All variants are intended for use in pulp capping and as protective bases under dental fillings, cements, or other restorative materials. They are regulated under FDA 510(k) and MDR classifications, with device class II designation. Storage conditions and sterility are manufacturer-specified for clinical use.

Frequently asked questions

Are these cavity liners reusable or intended for single-use only in clinical settings?

The Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) are explicitly supplied as single-use dental materials for clinical settings by dental professionals. This designation ensures sterility and safety for each patient application, preventing cross-contamination or degradation of material properties after use.

How do I prepare and apply the CalUltra variant compared to the other cavity liners?

CalUltra is a two-part base/catalyst system, meaning it requires mixing before application—unlike Apacal ART and Cal LC, which are light-curable pastes, or Calcigel, which is a ready-to-use paste. The mixing step ensures proper curing and effectiveness as a protective barrier for pulp capping or under restorative materials.

Which of these cavity liners are radiopaque, and why does that matter in dental procedures?

Apacal ART and Cal LC are radiopaque, meaning they appear visible on X-rays, which helps dentists confirm placement under restorative materials. Radiopacity is critical for verifying the liner’s position and ensuring it remains intact beneath fillings or cements, reducing the risk of pulp exposure or procedural errors.

What storage conditions should I follow for these cavity liners to maintain their integrity?

While the exact storage conditions are manufacturer-specified, the data confirms these are sterile, single-use dental materials intended for clinical settings. Proper storage—typically in a cool, dry place away from direct sunlight—is essential to preserve sterility and prevent degradation of the calcium hydroxide formulation before use.

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. Sources consulted: ApaCal ART - Prevest DenPro Limited, Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra), Cal LC - Prevest DenPro Limited, K212475 FDA 510(k) - Prevest Denpro Cavity Liners (Apacal ART

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Prevest Denpro Limited

Sources (2)

  • FDA 510(k) K212475 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026