# K242675: FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: Nov 1, 2024 after 56 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: 3 generations back to K943165 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062409: K-Etchant Gel, Kuraray Medical, Inc. (2006) Summary page 5.

## Most influential descendants
- K260485: Any-Etch (2026), 0 descendants of its own

## 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 sealant and teeth)

Source page: https://510kreport.com/device/K242675
Methodology: https://510kreport.com/methodology