# K130601: Bioroot RCS

- Pathway: 510(k) (Abbreviated)
- Applicant: Novocol, Inc.
- Decided: Oct 17, 2013 after 224 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K212283: BioRoot Flow 0.5g, BioRoot Flow 2g (2021), 0 descendants of its own

## Indications for use
BioRootTM RCS is intended to be used for permanent root canal filling in combination with gutta-percha points in vital or necrotic pulp cases or after a retreatment procedure. BioRootTM RCS is suitable for use in single cone technique or cold lateral condensation and is reserved for professional dental use only.

Source page: https://510kreport.com/device/K130601
Methodology: https://510kreport.com/methodology