# K132123: TRC-Pex, Radic-Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Km Corporation
- Decided: Mar 20, 2014 after 253 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: 3 generations back to K960548 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 2.
- K042769: Adseal Root Canal Sealer, Meta Biomed Co., Ltd. (2004) Summary page 2.
- K960548: AH Plus Root Canal Sealer, Dentsply Intl. (1996) Summary page 2.

## Indications for use
The TRC-Pex is a temiporary root canal sealer for use in the treatment of root canals, following a pulpeclomy or for apexegenesis or apexification. The Radic-Sealer is a root canal sealer for permanent sealing of root canals following established endlodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). The Radic-Sealer is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K132123
Methodology: https://510kreport.com/methodology