# K212283: BioRoot Flow 0.5g, BioRoot Flow 2g

- Pathway: 510(k) (Traditional)
- Applicant: Septodont
- Decided: Sep 16, 2021 after 57 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130601: Bioroot RCS, Novocol, Inc. (2013) Summary page 4.
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008) Summary page 4.

## Indications for use
* Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp. * Permanent root canal filling in combination with gutta-percha points following a retreatment procedure.

Source page: https://510kreport.com/device/K212283
Methodology: https://510kreport.com/methodology