BASE290 LED Curing Light
FDA 510(k) K233518 · Handpiece Headquarters
510(k) numberK233518
Submission
- Device name
- BASE290 LED Curing Light
- Applicant
- Handpiece Headquarters
Placentia, CA, US - Received
- November 1, 2023
- Decision date
- November 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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Questions and answers
When was BASE290 LED Curing Light cleared by the FDA?
BASE290 LED Curing Light (K233518) received a 510(k) decision of Substantially Equivalent on November 2, 2023, 1 days after the submission was received.
What is the product code of K233518?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.