Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005344591

FEI Number

3005344591

Entity Name

DMETEC CO., LTD

City/State/Country

Bucheon Gyeonggi, KR

Establishment Address

402-601,602,605 Bucheon-Techno-Park 655, Pyeongcheon-ro, Bucheon Gyeonggi 14502, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DMETEC Co., LTD (Owner Number: 10062186)

Owner / Operator Contact Address

402-601,602,605 Bucheon-Techno-Park 655, Pyeongcheon-ro, Bucheon, KR-41 14502, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051571

PMA Number

N/A

All Registered Proprietary Names

ULTRASONIC SURGERY MACHINE ACCURA Compact S, Compact S(LED) ULTRASONIC SURGERY SKYLIGHT LED CURING LIGHT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2020-05-15
EFH	Paper, Articulation	Dental	Class 1	872.6140	2019-12-26
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2020-05-15
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2020-05-15
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2020-05-15

Official Correspondent

Uibae Lee

US Agent Details

Sunyoung Park Email: sypark@szukorea.com Phone: (682) 7729233

Related Public Records

Same Entity

DMETEC Co., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005344591. Last updated year: 2026. Please use registration number 3005344591 when referencing this establishment in official correspondence.