# K082943: Iroot BP, Model Irbp 4609

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Bioceramix, Inc.
- Decided: Jan 6, 2009 after 96 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). 31 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063422: Bioaggregate, Innovative Bioceramix, Inc. (2006) Summary page 1.
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008)
- K952614: Jeltrate Plus Antimicrobial Impr. Material, Dentsply Intl. (1996) Summary page 1.
- (no number) Clearfil™ Ceramic Primer: named in the summary without a submission number

## Most influential descendants
- K092715: Iroot BP Plus (2009), 7 descendants of its own
- K180185: Bio-C Repair (2018), 3 descendants of its own
- K102867: Iroot FS (2010), 2 descendants of its own
- K243353: One-Fil Putty (2025), 1 descendant of its own
- K240365: Bioceramic Root Repair Material (C-Root BP) (2024), 1 descendant 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/K082943
Methodology: https://510kreport.com/methodology