# K231259: iRoot SP Plus

- Pathway: 510(k) (Special)
- Applicant: Innovative Bioceramix, Inc.
- Decided: May 31, 2023 after 30 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.
No later device cites it as a predicate yet.
0 of 30 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.

## 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.

Source page: https://510kreport.com/device/K231259
Methodology: https://510kreport.com/methodology