# K240365: Bioceramic Root Repair Material (C-Root BP)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing C-Root Dental Medical Devices Co., Ltd.
- Decided: May 10, 2024 after 94 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.
1 later device descends from it; 1 cites it directly.
0 of 38 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.

## Most influential descendants
- K242934: Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (2024), 0 descendants of its own

## Indications for use
*Repair of Root Perforation *Repair of Root Resorption *Root End Filling *Apexification *Pulp Capping

Source page: https://510kreport.com/device/K240365
Methodology: https://510kreport.com/methodology