# K201222: Bio-C Repair Ion+

- Pathway: 510(k) (Traditional)
- Applicant: Angelus Industria DE Produtos Odontologicos S/A
- Decided: Feb 11, 2021 after 281 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: 9 generations back to K990131 (1999). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180185: Bio-C Repair, Angelus Industria DE Produtos Odontologicos S/A (2018) Summary page 4.

## 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/K201222
Methodology: https://510kreport.com/methodology