K250015
- 510(k) number
- K250015
- Device name
- Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
- Applicant
- Ormco Corporation CA · US
- Product code
- DYH — Adhesive, Bracket And Tooth Conditioner, Resin
- Decision date
- 2025-01-03
- Date received
- 2025-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K250015.pdf
Official FDA record: K250015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.