# K983037: Roeko Seal

- Pathway: 510(k) (Traditional)
- Applicant: Roeko Ulm, Roescheisen GmbH & Co.
- Decided: Oct 20, 1998 after 50 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Lee Endo-Fill: named in the summary without a submission number

## Most influential descendants
- K212563: CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid (2022), 0 descendants of its own

## Indications for use
The Roeko Seal root canal sealer is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.

Source page: https://510kreport.com/device/K983037
Methodology: https://510kreport.com/methodology