K234043
- 510(k) number
- K234043
- Device name
- 3M Transbond Orthodontic Adhesive
- Applicant
- 3M Unitek Orthodontic Products CA · US
- Product code
- DYH — Adhesive, Bracket And Tooth Conditioner, Resin
- Decision date
- 2023-12-22
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K234043.pdf
Official FDA record: K234043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.