# K241977: Injectable Root Canal Bioceramic Sealer (i-MTA SP)

- Pathway: 510(k) (Traditional)
- Applicant: Longly Biotechnology (Wuhan) Co., Ltd.
- Decided: Oct 3, 2024 after 90 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: 8 generations back to K990131 (1999). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212983: Injectable Root Canal Bioceramic Sealer, Beijing C-Root Dental Medical Devices Co., Ltd. (2021) Summary page 6.

## Indications for use
Permanent obturation of the root canal following vital pulp-extirpation. Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings. i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and placement of intracanal dressings.

Source page: https://510kreport.com/device/K241977
Methodology: https://510kreport.com/methodology