Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010373494

FEI Number

3010373494

Entity Name

DENTIS MEDICAL DIVISION

City/State/Country

Daegu, KR

Establishment Address

6 Yuram-ro, Dong-gu,, Daegu 41065, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DENOPS ST300 ST300E ST500E ST500 Luvis Chair (LC700C-chair only plus) Luvis Chair (LC700C-chair only) Luvis Chair (LC700C) SA300 Series LUVIS-C200 Series LUVIS-C500 Series LUVIS-C100 Series LUVIS-C400 Series LUVIS-C300 Series LUVIS-C600 Series Medical LED Light (Luvis S) LUVIS-C700 Series E100 series(E1-M, E1-C, E1-W) S200 Series (Mobile, Ceiling, Dual Ceiling, Wall) L2S20-00210 (S200 Chair, S200 Dual Connection)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2021-09-21
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2024-08-16
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2024-02-19
KLC	Chair, Dental, With Operative Unit	Dental	Class 1	872.6250	2024-09-13
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2024-09-13
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2024-02-19
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2012-09-06
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2015-10-27

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
3033509587	DENTIS MEDICAL DIVISION	Dong-gu 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
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

Similar Registrations

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1058726	RUMEX INTERNATIONAL CO.	Tampa, FL, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3008242564	Septodont, Inc	Lancaster, PA, US
3012507533	Integra Canada ULC	Oakville Ontario, CA
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010373494. Last updated year: 2026. Please use registration number 3010373494 when referencing this establishment in official correspondence.