# K080266: Well-Pex

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Feb 6, 2008 after 5 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: 2 generations back to K973667 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032603: Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling, Meta Biomed Co., Ltd. (2003) Summary page 1.

## Indications for use
Well-Pex T 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 mot 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 mot canals, or following pulpectomy, or for apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

Source page: https://510kreport.com/device/K080266
Methodology: https://510kreport.com/methodology