ChecQ (AC100)— 510(k) K241065

Substantially Equivalent

Dentis Co., Ltd.

FDA 510(k) clearance K241065 for ChecQ (AC100), Substantially Equivalent on 2025-03-21. Applicant: Dentis Co., Ltd.. Device class: 1.

Clearance details

Applicant: Dentis Co., Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2024-04-18
Decision date: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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K233544 — MESHEET2024-02-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.