# K022734: Pulpdent Calcium Hydroxide Preparation

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Oct 7, 2002 after 52 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Neo/Diadent Vitapex Calcium Hydroxide Paste: named in the summary without a submission number
- (no number) ROEKO RSA RoekoSeal: named in the summary without a submission number

## 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

## Indications for use
PULPDENT CALCIUM HYDROXIDE PREPARA TlON is a biocompatible polydimethylsiloxane-based root canal sealer used for the temporary and permanent filling of root canals after endodontic surgery. PULPDENT CALCIUM HYDROXIDE PREPARATION can be used on its own, in conjunction with Gutta Percha and for vital pulpdectomies in deciduous teeth.

Source page: https://510kreport.com/device/K022734
Methodology: https://510kreport.com/methodology