# K180185: Bio-C Repair

- Pathway: 510(k) (Traditional)
- Applicant: Angelus Industria DE Produtos Odontologicos S/A
- Decided: Aug 31, 2018 after 220 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). 32 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 36 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 4.

## Most influential descendants
- K243353: One-Fil Putty (2025), 1 descendant of its own
- K251884: One-Fil Putty Injectable (2025), 0 descendants of its own
- K201222: Bio-C Repair Ion+ (2021), 0 descendants of its own

## Indications for use
Furcation or root perforation treatment via canal; Furcation or root perforation treatment via surgical; Internal reabsorption treatment via canal or surgical; External reabsorption treatment; Retrofilling in parendodontic surgery; Direct and indirect pulp capping; Apexification; Apexogenesis and Pulpotomy.

Source page: https://510kreport.com/device/K180185
Methodology: https://510kreport.com/methodology