K261129
- 510(k) number
- K261129
- Device name
- OrthoFit
- Applicant
- Spident Co., Ltd. KR
- Product code
- DYH — Adhesive, Bracket And Tooth Conditioner, Resin
- Decision date
- 2026-07-02
- Date received
- 2026-04-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261129.pdf
Official FDA record: K261129
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.