K260485
- 510(k) number
- K260485
- Device name
- Any-Etch
- Applicant
- Mediclus Co., Ltd. KR
- Product code
- KLE — Agent, Tooth Bonding, Resin
- Decision date
- 2026-05-14
- Date received
- 2026-02-13
- 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: K260485.pdf
Official FDA record: K260485
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.