K233161
- 510(k) number
- K233161
- Device name
- BeautiLink SA
- Applicant
- Shofu Dental Corporation CA · US
- Product code
- EMA — Cement, Dental
- Decision date
- 2023-09-28
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233161
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.