Dental Handpiece, Wireless Endodontic Handpiece, endoit
FDA 510(k) K232810 · Micro-Nx Co., Ltd.
510(k) numberK232810
Submission
- Device name
- Dental Handpiece, Wireless Endodontic Handpiece, endoit
- Applicant
- Micro-Nx Co., Ltd.
Dong-Gu, KR - Received
- September 12, 2023
- Decision date
- November 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dental Handpiece, Wireless Endodontic Handpiece, endoit cleared by the FDA?
Dental Handpiece, Wireless Endodontic Handpiece, endoit (K232810) received a 510(k) decision of Substantially Equivalent on November 9, 2023, 58 days after the submission was received.
What is the product code of K232810?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.