# K242934: Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)

- Pathway: 510(k) (Traditional)
- Applicant: Longly Biotechnology (Wuhan) Co., Ltd.
- Decided: Dec 12, 2024 after 78 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: 10 generations back to K990131 (1999). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240365: Bioceramic Root Repair Material (C-Root BP), Beijing C-Root Dental Medical Devices Co., Ltd. (2024) Summary page 5.

## Indications for use
i-MTA BP Bioceramic Root Canal Sealer and Repair Material 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/K242934
Methodology: https://510kreport.com/methodology