# K130312: Iroot FM

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Bioceramix, Inc.
- Decided: Sep 18, 2014 after 588 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008) Summary page 6.
- K063422: Bioaggregate, Innovative Bioceramix, Inc. (2006) Summary page 6.
- K033585: Diapex, Bisco, Inc. (2004) Summary page 6.
- (no number) iRoot FS: named in the summary without a submission number

## Indications for use
For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. These indications include application in: Apexification Periapical Lesions Root Resorption Temporary Root Filling Perforations Underdeveloped pulpless teeth

Source page: https://510kreport.com/device/K130312
Methodology: https://510kreport.com/methodology