K243720
- 510(k) number
- K243720
- Device name
- 3Delta UNlimited
- Applicant
- Deltamed GmbH DE
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2024-12-18
- Date received
- 2024-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243720
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.