# K093208: Simpliseal

- Pathway: 510(k) (Traditional)
- Applicant: Discus Dental, LLC
- Decided: Feb 12, 2010 after 122 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: 3 generations back to K960548 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042769: Adseal Root Canal Sealer, Meta Biomed Co., Ltd. (2004) Summary page 1.
- K960548: AH Plus Root Canal Sealer, Dentsply Intl. (1996) Summary page 1.

## Indications for use
SimpliSeal is a root canal sealer for the permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). SimpliSeal is intended for use by qualified healthcare personnel trained in its use,

Source page: https://510kreport.com/device/K093208
Methodology: https://510kreport.com/methodology