# K080917: Iroot SP

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Bioceramix, Inc.
- Decided: Apr 9, 2008 after 8 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: 6 generations back to K990131 (1999). 28 ancestors in all.
37 later devices descend from it; 12 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960548: AH Plus Root Canal Sealer, Dentsply Intl. (1996) Summary page 1.
- K063422: Bioaggregate, Innovative Bioceramix, Inc. (2006) Summary page 1.
- K893794: Apexit Root Canal Sealer, Williams Dental Co., Inc. (1989) Summary page 1.
- K020078: Exactech Resorbable Bone Paste, Exactech, Inc. (2004) Summary page 1.
- K060732: MBCP Gel, Biomatlante (2006) Summary page 1.
- K033585: Diapex, Bisco, Inc. (2004) Summary page 1.

## Most influential descendants
- K082943: Iroot BP, Model Irbp 4609 (2009), 12 descendants of its own
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K092715: Iroot BP Plus (2009), 7 descendants of its own
- K212983: Injectable Root Canal Bioceramic Sealer (2021), 4 descendants of its own
- K180185: Bio-C Repair (2018), 3 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. iRoot SP is suitable for use in the single cone and lateral condensation technique.

Source page: https://510kreport.com/device/K080917
Methodology: https://510kreport.com/methodology