K243370
- 510(k) number
- K243370
- Device name
- DentaTOOTH
- Applicant
- Asiga Pty, Ltd. AU
- Product code
- EBG — Crown And Bridge, Temporary, Resin
- Decision date
- 2025-05-05
- Date received
- 2024-10-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243370.pdf
Official FDA record: K243370
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.