K243621
- 510(k) number
- K243621
- Device name
- Evoblock, Perléon
- Applicant
- Evoden Indústria Comércio Importação E Exportação BR
- Product code
- EBG — Crown And Bridge, Temporary, Resin
- Decision date
- 2025-04-22
- Date received
- 2024-11-22
- 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: K243621
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.