K240538
- 510(k) number
- K240538
- Device name
- Premium Teeth Resin
- Applicant
- Formlabs Ohio, Inc. OH · US
- Product code
- EBG — Crown And Bridge, Temporary, Resin
- Decision date
- 2024-07-19
- Date received
- 2024-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240538.pdf
Official FDA record: K240538
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.