# K222992: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Bioceramix, Inc.
- Decided: Nov 22, 2022 after 55 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: 10 generations back to K990131 (1999). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142178: Proroot Mta White, Proroot Mta Gray, Dentsply International, Inc. (2015) Summary page 4.
- K082943: Iroot BP, Model Irbp 4609, Innovative Bioceramix, Inc. (2009) Summary page 4.
- K092715: Iroot BP Plus, Innovative Bioceramix, Inc. (2009) Summary page 4.
- K102867: Iroot FS, Innovative Bioceramix, Inc. (2010) Summary page 4.

## Indications for use
-Repair of Root Perforation -Repair of Root Resorption -Root End Filling -Apexification -Pulp capping -Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages >12-21 years).

Source page: https://510kreport.com/device/K222992
Methodology: https://510kreport.com/methodology