Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008559238

FEI Number

3008559238

Entity Name

LAKONG MEDICAL DEVICES CO., LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No. 13 Jingci Road, Shilong, Dongguan Guangdong 523326, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Lakong Medical Devices Co., Ltd. (Owner Number: 10033552)

Owner / Operator Contact Address

NO. 13 JINGCI ROAD, SHILONG TOWN, DONGGUAN, CN-GD 523326, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

X-ray Viewer Autoclave Indicator Tape Impression Syring/Material FACE SHIELD AdvanceCam Intra oral Camera & accessories X-ray film mounting, holder, positioner Dental air compressor Mobile-Vac SteriFlock Sterile Collection Swabs Perio Scaler, dental Ultrasonic Scaler Dental Gauze/sponge, non-sterile DENTAL CHAIR Vacuum unit Stool, Portable Stool Fluoride Tray, Disposable Hand instruments Dental cotton roll, saliva absorbent Ultrasonic Cleaner - denture PC Family Portable Dental System EYE SHIELD Face Mask D650N Digital Amalgamator Air Water Syringes, Syringe Tips - Metal & Disposable Utility tray, Surgical tips, Articulator advanceCAM TPC Operatory Light Digital Thermometer H6000 Handpiece Cleaning and Lubrication System Lubricant Non Sterile Micro Applicators Polishing powder ISOLATION GOWN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IXC	Illuminator, Radiographic-Film	Radiology	Class 1	892.1890	2012-11-30
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-01-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-01-06
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2021-11-02
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-16
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2011-07-15
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2011-07-15
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2021-11-02
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2018-12-10
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-05-21
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2010-08-30
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2014-02-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-10-24
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2014-02-23
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2021-11-02
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2017-01-26
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2024-10-24
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2021-11-02
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-10-24
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2010-08-30
FZK	Chair, Surgical, Non-Electrical	General, Plastic Surgery	Class 1	878.4950	2017-01-26
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-16
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-06
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2011-01-31
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2010-08-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-05-03
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2013-11-21
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2017-01-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-05-19
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2010-08-30
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2010-08-30
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2011-07-15
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-11

Official Correspondent

Nancy Lai

US Agent Details

Van Wang Business: TPC Advanced Technology, Inc. Email: vwang@tpcdental.com Phone: (626) 8104337

Related Public Records

Same Entity

Lakong Medical Devices 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
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

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3010131137	BIOTRONIX HEALTHCARE INDUSTRIES INC.	Orlando, FL, US
3030126955	ONVET MEDICAL CANADA INC	TORONTO Ontario, CA
2031508	TPC ADVANCED TECHNOLOGY, INC.	City Industry, CA, US
3015223105	GALAXY INDIA	NEW DELHI, IN
3004475699	GUANGDONG YUEHUA MEDICAL INSTRUMENT FACTORY CO., LTD.	Shantou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008559238. Last updated year: 2026. Please use registration number 3008559238 when referencing this establishment in official correspondence.