FDA Registration
Active
🇨🇳 China
LAKONG MEDICAL DEVICES CO., LTD.
Reg #: 3008559238
·
FEI: 3008559238
·
Expires 2026
Products
39
Proprietary Names
40
Establishment Types
5
Classifications
39
Registration Details
- Registration Name
- LAKONG MEDICAL DEVICES CO., LTD.
- Registration Number
- 3008559238
- FEI Number
- 3008559238
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 13 Jingci Road, Shilong
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K103498
Owner / Operator
- Firm Name
- Lakong Medical Devices Co., Ltd.
- Operator Number
- 10033552
- Address
- NO. 13 JINGCI ROAD, SHILONG TOWN
- City
- DONGGUAN
- State
- Guangdong
- Postal Code
- 523326
- Country
- CN
- Correspondent
- Nancy Lai
US Agent
- Business Name
- TPC Advanced Technology, Inc.
- Contact Name
- Van Wang
- Address
- 851 S. Lawson Street
- City
- City Industry
- State
- CA
- ZIP
- 91748
- Country
- US
- [email protected]
- Phone
- 626 8104337
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Illuminator, Radiographic-Film | IXC | Class 1 | Radiology | No | 2012-11-30 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2025-01-06 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2025-01-06 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2021-11-02 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-16 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2011-07-15 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2011-07-15 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2021-11-02 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2018-12-10 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-05-21 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2010-08-30 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2014-02-23 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-10-24 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2014-02-23 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2021-11-02 |
| Stool, Operating-Room | FZM | Class 1 | General, Plastic Surgery | No | 2017-01-26 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2024-10-24 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2021-11-02 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2024-10-24 |
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2010-08-30 |
| Chair, Surgical, Non-Electrical | FZK | Class 1 | General, Plastic Surgery | No | 2017-01-26 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-04-16 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-06 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2011-01-31 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2010-08-30 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-05-03 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2013-11-21 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2017-01-26 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-05-19 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2010-08-30 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2010-08-30 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2011-07-15 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-06-11 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 2021-11-02 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2010-08-30 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2011-06-20 |
| Light, Fiber Optic, Dental | EAY | Class 1 | Dental | No | 2021-11-02 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-04-13 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2014-12-11 |
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
Mobile delivery cabinet
Handpiece, Metal Quick Disconnect
disposable rubber cup
Prophylaxis, cups, brushes and angles
Fiber optic/Dental delivery unit
N95 FACE MASK
Ultrasonic cleaner
Establishment Types
Manufacture Medical Device
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device
Remanufacture Medical Device
Repack or Relabel Medical Device