# K032605: Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Oct 8, 2003 after 44 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
Longest line of descent: 1 generation back to K944945 (1994). 2 ancestors in all.
7 later devices descend from it; 3 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)
- K022734: Pulpdent Calcium Hydroxide Preparation, Pulpdent Corporation (2002) Summary page 2.
- K944945: Pulpdent Calcium Hydroxide Preparations, Pulpdent Corp. (1994) Summary page 2.

## Most influential descendants
- 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
- K253167: Any-Paste (2026), 0 descendants of its own

## Indications for use
For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomies in decidious teeth. Metapaste is intended for use by qualified healthcare personnel trained in its use,

Source page: https://510kreport.com/device/K032605
Methodology: https://510kreport.com/methodology