# K182009: Dia-Proseal

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Sep 26, 2019 after 426 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 4.

## Indications for use
DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points.

Source page: https://510kreport.com/device/K182009
Methodology: https://510kreport.com/methodology