# K060365: Apexcal

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Apr 17, 2006 after 63 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K201799: CleaniCal (2021), 2 descendants of its own
- K261514: Calcium Hydroxide Temporary Filling Material (KP-Cal) (2026), 0 descendants of its own
- K212475: Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) (2022), 0 descendants of its own
- K211905: UltraCal XS (2021), 0 descendants of its own

## Indications for use
ApexCAL is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including: * Temporary disinfectant dressings in the obturation of root canals; * Indirect pulp capping or management of deep caries lesions; or * Direct pulp capping.

Source page: https://510kreport.com/device/K060365
Methodology: https://510kreport.com/methodology