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Data / Medical devices / China / Lakong Medical Devices Co., Ltd.

Lakong Medical Devices Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 5 510(k) clearances

Lakong Medical Devices Co., Ltd. is registered with the FDA (registration 3008559238) in Dongguan Guangdong, China. It lists 42 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Lakong Medical Devices Co., Ltd.
FDA registration number
3008559238
Address
No. 13 Jingci Road Shilong, Dongguan Guangdong, China, 523326
Owner or operator
Lakong Medical Devices Co., Ltd. (10033552)
Roles
Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler
First device listed
August 30, 2010
Registered through
2026
Brand names listed
AdvanceCam Intra oral Camera & accessories, Air Water Syringes, Syringe Tips - Metal & Disposable, Autoclave Indicator Tape, D650N Digital Amalgamator, DENTAL CHAIR, Dental Gauze/sponge, non-sterile, Dental air compressor, Dental cotton roll, saliva absorbent and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufactureraccessdata.fda.gov
Amalgamator, Dental, Ac-PoweredEFD1Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Manufactureraccessdata.fda.gov
Cabinet, Table And Tray, AnesthesiaBRY1Manufactureraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Chair, Dental, With Operative UnitKLC1Manufactureraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Manufactureraccessdata.fda.gov
Chair, Surgical, Non-ElectricalFZK1Manufactureraccessdata.fda.gov
Cleaner, Denture, MechanicalJER1Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Manufactureraccessdata.fda.gov
Compressor, Air, PortableBTI2Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Cup, ProphylaxisEHK1Manufactureraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Manufactureraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Manufactureraccessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaQKRNExporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Holder, Film, X-RayEGZ1Manufactureraccessdata.fda.gov
Illuminator, Radiographic-FilmIXC1Manufactureraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Foreign private label distributoraccessdata.fda.gov
Instrument, Hand, Calculus RemovalELA1Manufactureraccessdata.fda.gov
Light, Fiber Optic, DentalEAY1Manufactureraccessdata.fda.gov
Light, Operating, DentalEAZ1Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Portable Dental Operative UnitSJH1Manufactureraccessdata.fda.gov
Respirator, SurgicalMSH2Repackager or relabeleraccessdata.fda.gov
Scaler, PeriodonticEMN1Manufactureraccessdata.fda.gov
Scaler, UltrasonicELC2Manufactureraccessdata.fda.gov
Scanner, ColorKZN2Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Stool, Operating-RoomFZM1Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufactureraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Unit, Operative DentalEIA1Manufacturer, Remanufactureraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Manufactureraccessdata.fda.gov
Unit, Suction OperatoryEBR1Manufactureraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Manufactureraccessdata.fda.gov
Wrap, SterilizationFRG2Foreign private label distributoraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 10, 2026K254009Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)SJHSubstantially EquivalentLakong Medical Devices Co., Ltd.accessdata.fda.gov
August 7, 2026K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)EIASubstantially EquivalentLakong Medical Devices Co., Ltd.accessdata.fda.gov
November 28, 2018K180207Non-contact Infrared ThermometerFLLSubstantially EquivalentAlicn Medical (Shenzhen), Inc.accessdata.fda.gov
March 31, 2011K103498LAKONG ULTRASONIC SCALERELCSubstantially EquivalentLakong Medical Device Company, Ltd.accessdata.fda.gov
August 28, 2007K071485TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888EIASubstantially EquivalentTpc Advanced Technology, Inc.accessdata.fda.gov

Compare with other makers

Updated September 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.