# K971642: Dentalis Kez Endodonitc Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Neodental Chemical Products Co., Ltd.
- Decided: Jul 24, 1997 after 83 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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
For use in the sealing of preparad root canals in aduit or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to promote healing effects and to help prevent bacterial contamination of the canal.

Source page: https://510kreport.com/device/K971642
Methodology: https://510kreport.com/methodology