# K102867: Iroot FS

- Pathway: 510(k) (Special)
- Applicant: Innovative Bioceramix, Inc.
- Decided: Dec 3, 2010 after 64 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: 9 generations back to K990131 (1999). 37 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082943: Iroot BP, Model Irbp 4609, Innovative Bioceramix, Inc. (2009) Summary page 1.
- K092715: Iroot BP Plus, Innovative Bioceramix, Inc. (2009) Summary page 1.
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008) Summary page 1.
- K851606: D-PBS, Products NO. D5652, Sigma Chemical Co. (1985) Summary page 1.

## Most influential descendants
- K213757: Endocem MTA Premixed Regular (2023), 0 descendants of its own
- K222992: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material (2022), 0 descendants of its own

## Indications for use
Repair of Root Perforation Repair of Root Resorption Root End Filling Apexification Pulp Capping

Source page: https://510kreport.com/device/K102867
Methodology: https://510kreport.com/methodology