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510(k) K242646

Dental Implant Unit by Guilin Aesthedent Medical Instruments Co., Ltd. — Product Code EBW

K242646 is an FDA 510(k) premarket notification submitted by Guilin Aesthedent Medical Instruments Co., Ltd. for the device "Dental Implant Unit". The FDA issued a decision of Substantially Equivalent on April 11, 2025. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2025
Date Received
September 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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FDA data resources