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510(k) K241065

ChecQ (AC100) by Dentis Co., Ltd. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2025
Date Received
April 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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Other clearances for product code EKX

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  • K232657 — InnerView LC (September 1, 2023)