# K172701: Bio-C Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Angelus Industria DE Produtos Odontologicos S/A
- Decided: Jan 4, 2018 after 119 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). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008) Summary page 4.
- K140247: Mta Fillapex, Angelus Industria DE Productos Odontologicos SA (2014) Summary page 4.
- K151047: MTA Repair HP, Angelus Industria DE Productos Odontologicos (2016) Summary page 4.

## Most influential descendants
- K190537: BIO-C Sealer Ion+ (2019), 0 descendants of its own

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

Source page: https://510kreport.com/device/K172701
Methodology: https://510kreport.com/methodology