K233518
- 510(k) number
- K233518
- Device name
- BASE290 LED Curing Light
- Applicant
- Handpiece Headquarters CA · US
- Product code
- EBZ — Activator, Ultraviolet, For Polymerization
- Decision date
- 2023-11-02
- Date received
- 2023-11-01
- 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: K233518
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.