# K120003: NUCAL

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Apr 5, 2012 after 93 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: 1 generation back to K944945 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944945: Pulpdent Calcium Hydroxide Preparations, Pulpdent Corp. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K094945: Pulpdent Multi-Cal. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K901714: Lifestyle Home Tanning Units, Life Products, Inc. (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste used as a cavity liner and as a temporary root canal dressing.

Source page: https://510kreport.com/device/K120003
Methodology: https://510kreport.com/methodology