# K212983: Injectable Root Canal Bioceramic Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Beijing C-Root Dental Medical Devices Co., Ltd.
- Decided: Dec 8, 2021 after 82 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: 7 generations back to K990131 (1999). 29 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008) Summary page 4.

## Most influential descendants
- K240304: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) (2024), 2 descendants of its own
- 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
- K241977: Injectable Root Canal Bioceramic Sealer (i-MTA SP) (2024), 0 descendants of its own

## Indications for use
* Permanent obturation of the root canal following vital pulpextirpation. * Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings. C-Root SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.

Source page: https://510kreport.com/device/K212983
Methodology: https://510kreport.com/methodology