# K260819: Any-Com Seal

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: May 1, 2026 after 49 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K161580 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243254: Parkell Pit and Fissure Sealant, Parkell, Inc. (2025) Summary page 5.

## Indications for use
It is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations.

Source page: https://510kreport.com/device/K260819
Methodology: https://510kreport.com/methodology