# K060946: CZ-S2000

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Jun 15, 2006 after 70 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. The FDA summary names its predicate without a number.
- (no number) Adseal: named in the summary without a submission number
- (no number) Endorez: named in the summary without a submission number
- (no number) First Fill: named in the summary without a submission number
- (no number) Sealapex: named in the summary without a submission number

## Indications for use
A biocompatible, radiopaque, resin-based, self-etching, dual-cure, two-part (powder and liquid) root canal sealer that is capable of bonding with gutta percha or resinous points as well as the surrounding walls of a properly reamed and filed root canal to affect a durable seal of that canal.

Source page: https://510kreport.com/device/K060946
Methodology: https://510kreport.com/methodology