# K190537: BIO-C Sealer Ion+

- Pathway: 510(k) (Abbreviated)
- Applicant: Angelus Industria DE Produtos Odontologicos S/A
- Decided: Dec 12, 2019 after 283 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). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172701: Bio-C Sealer, Angelus Industria DE Produtos Odontologicos S/A (2018) Summary page 4.

## Indications for use
1. Sealing the root canal of permanent teeth; 2. Internal reabsorption treatment;

Source page: https://510kreport.com/device/K190537
Methodology: https://510kreport.com/methodology