# K242702: VioSeal

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: Nov 7, 2024 after 59 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: 1 generation back to K960548 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960548: AH Plus Root Canal Sealer, Dentsply Intl. (1996) Summary page 5.

## Indications for use
Permanent obturation of root canals of the permanent teeth in combination with root canal points

Source page: https://510kreport.com/device/K242702
Methodology: https://510kreport.com/methodology