Dental Implantation Systems, Dental Electrical Motors
FDA 510(k) K220831 · Foshan Coxo Medical Instrument Co., Ltd.
510(k) numberK220831
Submission
- Device name
- Dental Implantation Systems, Dental Electrical Motors
- Applicant
- Foshan Coxo Medical Instrument Co., Ltd.
Foshan, CN - Received
- March 22, 2022
- Decision date
- September 27, 2022
- 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 Implantation Systems, Dental Electrical Motors cleared by the FDA?
Dental Implantation Systems, Dental Electrical Motors (K220831) received a 510(k) decision of Substantially Equivalent on September 27, 2022, 189 days after the submission was received.
What is the product code of K220831?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.