# K944945: Pulpdent Calcium Hydroxide Preparations

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Nov 30, 1994 after 54 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032605: Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling (2003), 7 descendants of its own
- K210904: Metapaste Plus (2021), 2 descendants of its own
- K190091: Diapaste (2020), 2 descendants of its own
- K210333: DiaPaste (2021), 1 descendant of its own
- K261514: Calcium Hydroxide Temporary Filling Material (KP-Cal) (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K944945
Methodology: https://510kreport.com/methodology