# K201799: CleaniCal

- Pathway: 510(k) (Traditional)
- Applicant: Maruchi
- Decided: Feb 12, 2021 after 227 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: 8 generations back to K990131 (1999). 41 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060365: Apexcal, Ivoclar Vivadent, Inc. (2006) Summary page 4.
- K170175: Endoseal Mta, Maruchi (2018) Summary page 4.

## Most influential descendants
- 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
CleaniCal 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/K201799
Methodology: https://510kreport.com/methodology