# K212475: Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

- Pathway: 510(k) (Traditional)
- Applicant: Prevest Denpro Limited
- Decided: May 13, 2022 after 280 days
- Product code: EJK (Liner, Cavity, Calcium Hydroxide)
- Device class: 2
- Regulation: 21 CFR 872.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K990131 (1999). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201799: CleaniCal, Maruchi (2021) Summary page 6.
- K970113: Ultra-Blend Plus, Ultradent Products, Inc. (1997) Summary page 6.
- K150559: Life Fast Set, Life Regular Set, Sybron Dental Specialties (2015) Summary page 6.

## Indications for use
Apacal ART and is suitable for several indications including: * Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. * Indirect pulp capping or management of deep caries lesions, or * Direct pulp capping CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled. Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including: * Indirect pulp capping or management of deep caries lesions, or * Direct pulp capping CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.

Source page: https://510kreport.com/device/K212475
Methodology: https://510kreport.com/methodology