K251946
- 510(k) number
- K251946
- Device name
- G aenial Universal Injectable II
- Applicant
- GC America, Inc. IL · US
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2025-08-29
- Date received
- 2025-06-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251946.pdf
Official FDA record: K251946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.