# K260485: Any-Etch

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: May 14, 2026 after 90 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943165 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242675: FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack), Spident Co., Ltd. (2024) Summary page 5.

## Indications for use
- Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth) - Remove smear layer of dentin and enamel - Pretreatment etchant before sealant (help to having a strong bonding strength between resin and teeth)

Source page: https://510kreport.com/device/K260485
Methodology: https://510kreport.com/methodology