Lakong Medical Devices Co., Ltd.
Registered establishment in Dongguan, Guangdong, China. 39 device types, 1 clearance.
Lakong Medical Devices Co., Ltd. is a remanufacturer holding a current FDA establishment registration. The registration covers Cotton, Roll, Cup, Prophylaxis and 37 other device types. Its earliest product listing with the FDA dates from 2010.
39device types registered with the FDA
1510(k) clearance
Registration
| Registered name | LAKONG MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008559238 |
| FEI number | 3008559238 |
| Establishment type | Remanufacturer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 东莞立港医疗器材有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | No. 13 Jingci Road |
| Postal code | 523326 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Shield | 2020 | 439 |
| Agent, Polishing, Abrasive, Oral Cavity | Class 1 | Polishing powder | 2011 | 25 |
| Amalgamator, Dental, Ac-Powered | Class 1 | D650N Digital Amalgamator | 2011 | 4 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Non Sterile Micro Applicators | 2010 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | SteriFlock Sterile Collection Swabs | 2020 | 100 |
| Cabinet, Table And Tray, Anesthesia | Class 1 | Mobile delivery cabinet | 2021 | 22 |
| Camera, Surgical And Accessories | Class 1 | AdvanceCam Intra oral Camera & accessories | 2011 | 22 |
| Chair, Dental, Without Operative Unit | Class 1 | Dental Chair | 2014 | 38 |
| Chair, Surgical, Non-Electrical | Class 1 | PC Family Portable Dental System | 2017 | 4 |
| Cleaner, Denture, Mechanical | Class 1 | Ultrasonic Cleaner – denture | 2010 | 12 |
| Cleaner, Ultrasonic, Medical Instrument | Class 1 | Ultrasonic cleaner | 2014 | 48 |
| Compressor, Air, Portable | Class 2 | Dental air compressor | 2021 | 23 |
| Continuous Measurement Thermometer | Class 2 | Digital Thermometer | 2020 | 115 |
| Cotton, Roll | Class 1 | Dental cotton roll, saliva absorbent | 2024 | 107 |
| Cup, Prophylaxis | Class 1 | disposable rubber cup, Prophylaxis, cups, brushes and angles | 2011 | 49 |
| Drill, Dental, Intraoral | Class 1 | Handpiece, Metal Quick Disconnect | 2010 | 20 |
| Evacuator, Oral Cavity | Class 1 | Mobile-Vac | 2018 | 49 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face Mask | 2020 | 182 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Dental Gauze/sponge, non-sterile | 2024 | 266 |
| Holder, Film, X-Ray | Class 1 | X-ray film mounting, holder, positioner | 2011 | 40 |
| Illuminator, Radiographic-Film | Class 1 | X-ray Viewer | 2012 | 5 |
| Indicator, Physical/Chemical Sterilization Process | Class 2 | Autoclave Indicator Tape | 2025 | 19 |
| Instrument, Hand, Calculus Removal | Class 1 | Hand instruments | 2021 | 13 |
| Light, Fiber Optic, Dental | Class 1 | Fiber optic/Dental delivery unit | 2021 | 2 |
| Light, Operating, Dental | Class 1 | TPC Operatory Light | 2017 | 16 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
| Respirator, Surgical | Class 2 | N95 Face Mask | 2020 | 118 |
| Scaler, Periodontic | Class 1 | Perio Scaler, dental | 2010 | 34 |
| Scaler, Ultrasonic | Class 2 | Ultrasonic Scaler | 2014 | 14 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | EYE Shield | 2020 | 384 |
| Stool, Operating-Room | Class 1 | Stool, Portable Stool | 2017 | 16 |
| Syringe, Restorative And Impression Material | Class 1 | Impression Syring/Material | 2021 | 49 |
| Tray, Fluoride, Disposable | Class 1 | Fluoride Tray, Disposable | 2024 | 22 |
| Tray, Surgical, Instrument | Class 1 | Utility tray, Surgical tips, Articulator | 2012 | 105 |
| Unit, Operative Dental | Class 1 | advanceCAM | 2013 | 13 |
| Unit, Operative Dental, Accessories | Class 1 | H6000 Handpiece Cleaning and Lubrication System, Lubricant | 2010 | 65 |
| Unit, Suction Operatory | Class 1 | Vacuum unit | 2021 | 23 |
| Unit, Syringe, Air And/Or Water | Class 1 | Air Water Syringes, Syringe Tips – Metal & Disposable | 2010 | 56 |
| Wrap, Sterilization | Class 2 | Autoclave Indicator Tape | 2025 | 38 |
Clearances
1 clearance names Lakong Medical Devices Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251544 | 2026-08-07 | EIA | Traditional | This company |
| K180207 | 2018-11-28 | FLL | Traditional | Alicn Medical Shenzhen, Inc |
| K103498 | 2011-03-31 | ELC | Traditional | Lakong Medical Device Company, Ltd. |
| K071485 | 2007-08-28 | EIA | Traditional | TPC Advanced Technology, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1994 |
|---|---|
| Employees | 300 |
| Main products | Dental chairs, Portable dental units, Air compressors, Intraoral cameras, LED curing lights |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.