# K240304: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

- Pathway: 510(k) (Traditional)
- Applicant: Enpuno Biotechnology Co., Ltd.
- Decided: May 28, 2024 after 116 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.
2 later devices descend from it; 1 cites it directly.
0 of 33 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 5.

## Most influential descendants
- K250710: Injectable Root Canal Bioceramic Sealer (nRoot SP) (2025), 1 descendant of its own
- K253909: NeoPEX™ Pre-Mixed Obturation Paste (2026), 0 descendants of its own

## 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. Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.

Source page: https://510kreport.com/device/K240304
Methodology: https://510kreport.com/methodology