# K133716: TRC-Paste

- Pathway: 510(k) (Traditional)
- Applicant: Km Corporation
- Decided: Apr 9, 2014 after 125 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
TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or following pulpectomy, or for apexegenesis or apexification, and for the tip filling of prepared treated root canals at the time of final filling with gutta-percha.

Source page: https://510kreport.com/device/K133716
Methodology: https://510kreport.com/methodology