DENTIS MEDICAL DIVISION

FDA Device Registration & Listing · Dong-gu Daegu, KR · Registration 3033509587

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033509587
FEI Number
3033509587
Entity Name
DENTIS MEDICAL DIVISION
City/State/Country
Dong-gu Daegu, KR
Establishment Address
F1, 102, 87, Yuram-ro, Dong-gu Daegu 41059, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Dentis Co., Ltd. (Owner Number: 10025697)
Owner / Operator Contact Address
99, Seongseoseo-ro, Dalseo-gu, Daegu, KR-27 42718, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

ChecQ (AC100)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2025-03-26

Official Correspondent

No official correspondent registered.

US Agent Details

April Lee Business: Withus Group Inc Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

Dentis Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3036190511 Dentis Co.,Ltd Dong-gu Daegu, KR
3010373494 DENTIS MEDICAL DIVISION Daegu, KR
3007031098 DENTIS CO., LTD. Daegu, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K241065 Dentis Co., Ltd. ChecQ (AC100) 2025-03-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033509587. Last updated year: 2026. Please use registration number 3033509587 when referencing this establishment in official correspondence.
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