K242537
- 510(k) number
- K242537
- Device name
- BracePaste Fluoride Sealant
- Applicant
- American Orthodontics Corp. WI · US
- Product code
- DYH — Adhesive, Bracket And Tooth Conditioner, Resin
- Decision date
- 2024-08-27
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242537.pdf
Official FDA record: K242537
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.