# K092715: Iroot BP Plus

- Pathway: 510(k) (Special)
- Applicant: Innovative Bioceramix, Inc.
- Decided: Sep 28, 2009 after 25 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: 8 generations back to K990131 (1999). 35 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 43 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.
- K063422: Bioaggregate, Innovative Bioceramix, Inc. (2006) Summary page 1.
- K875133: Cavit-W, Espe GmbH (Us) (1988) Summary page 1.
- K050906: Vitalcare I.V. Administration Set, Vitalcare Group, Inc. (2005) Summary page 1.

## Most influential descendants
- K102867: Iroot FS (2010), 2 descendants of its own
- K240365: Bioceramic Root Repair Material (C-Root BP) (2024), 1 descendant of its own
- K251465: Root canal repair materials (nRoot BP) (2025), 0 descendants of its own
- K242934: Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (2024), 0 descendants of its own
- K232299: CeraPutty (2023), 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/K092715
Methodology: https://510kreport.com/methodology