# K251465: Root canal repair materials (nRoot BP)

- Pathway: 510(k) (Traditional)
- Applicant: Enpuno Biotechnology Co., Ltd.
- Decided: Sep 25, 2025 after 135 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: 9 generations back to K990131 (1999). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092715: Iroot BP Plus, Innovative Bioceramix, Inc. (2009) Summary page 5.

## Indications for use
Root canal repair materials (nRoot BP) is developed for permanent root canal sealer and repair and surgical applications. *Repair of Root Perforation *Repair of Root Resorption * Root End Filling *Apexification * Pulp Capping

Source page: https://510kreport.com/device/K251465
Methodology: https://510kreport.com/methodology