HPR Cordless Hygiene Handpiece
FDA 510(k) K243911 · Handpiece Headquarters
510(k) numberK243911
Submission
- Device name
- HPR Cordless Hygiene Handpiece
- Applicant
- Handpiece Headquarters
Placentia, CA, US - Received
- December 19, 2024
- Decision date
- December 20, 2024
- 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 HPR Cordless Hygiene Handpiece cleared by the FDA?
HPR Cordless Hygiene Handpiece (K243911) received a 510(k) decision of Substantially Equivalent on December 20, 2024, 1 days after the submission was received.
What is the product code of K243911?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.