# K261129: OrthoFit

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: Jul 2, 2026 after 87 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K150128 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150128: GC Ortho Connect, GC Ortho Etching Gel, Gc Orthodontics America, Inc. (2015) Summary page 5.

## Indications for use
Bonding of orthodontic brackets, bands, and other orthodontic attachments (such as buttons and cleats). Fixation of lingual retainers.

Source page: https://510kreport.com/device/K261129
Methodology: https://510kreport.com/methodology