# K180199: Bio-C Temp

- Pathway: 510(k) (Traditional)
- Applicant: Angelus Industria DE Produtos Odontologicos S/A
- Decided: Jan 4, 2019 after 345 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
- Intracanal dressing for endodontic treatment of pulp necrosis and retreatments. - Intracanal dressing in cases of perforations, external and internal resorptions, prior to the use of MTA ANGELUS OR MTA REPAIR HP. - For the treatment of incomplete root formation (rizogenesis): Apexification — the formation of the apex in cases of pulp necrosis; Apexigenesis — the formation of the apex in cases of vital pulp.

Source page: https://510kreport.com/device/K180199
Methodology: https://510kreport.com/methodology