# K032603: Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Oct 7, 2003 after 43 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 K973667 (1997). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973667: Vitapex Pre-Loaded Dental Syringe, Neodental Chemical Products Co., Ltd. (1997) Summary page 2.

## Most influential descendants
- K182625: Diapex Plus (2019), 1 descendant of its own
- K202617: Metapex Plus (2021), 0 descendants of its own
- K133716: TRC-Paste (2014), 0 descendants of its own
- K132123: TRC-Pex, Radic-Sealer (2014), 0 descendants of its own
- K080266: Well-Pex (2008), 0 descendants of its own

## Indications for use
Metapex calcium hydroxide with Iodoform is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexificaation, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. Metapex is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K032603
Methodology: https://510kreport.com/methodology