Manufacturer registered with FDA
Lakong Medical Devices Co., Ltd.
DONGGUAN, China. Lists 23 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 23
- Brands and models
- 26
- 510(k) clearances
- 22026–2026
- Markets registered in
- 628 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Lakong Medical Devices Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Lakong Medical Devices Co., Ltd. | 2 clearances | 2026–2026 | Below |
| South Korea | MFDS | Manufacturer | LAKONG MEDICAL DEVICES CO LTDLAKONG MEDICAL DEVICES CO.,LTD, · LAKONG MEDICAL DEVICES CO.,LTD. · +2 | 13 | 2011–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Lakong Medical Devices Co., Ltd. | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Lakong Medical Devices Co., Ltd. | 5 | 2017–2017 | Pure Global AI |
| Australia | TGA | Manufacturer | Lakong Medical Devices Co Ltd | 1 | 2012–2012 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LAKONG MEDICAL DEVICES CO., LTD. | 1 | 2019–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Lakong Medical Devices Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | advanceCAMLaguna 2, Mirage 2 dental chair with delivery unit operatory package | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Handpiece, Metal Quick Disconnect | 2010 |
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Maker | Fiber optic/Dental delivery unit | 2021 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | TPC Operatory Light | 2017 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Vacuum unit | 2021 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air Water Syringes, Syringe Tips - Metal & Disposable | 2010 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | D650N Digital Amalgamator | 2011 |
| Roll CottonEFN · Class 1 | — | Lister | Dental cotton roll, saliva absorbent | 2024 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | X-ray film mounting, holder, positioner | 2011 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | disposable rubber cupProphylaxis, cups, brushes and angles | 2011 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Mobile-Vac | 2018 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Impression Syring/Material | 2021 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Polishing powder | 2011 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | Hand instruments | 2021 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Ultrasonic Scaler | 2014 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Perio Scaler, dental | 2010 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | Ultrasonic Cleaner - denture | 2010 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Maker | Laguna 2, Mirage 2 dental chair with delivery unit operatory package | 2026 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | Fluoride Tray, Disposable | 2024 |
| Color ScannerKZN · Class 2 | — | Lister | Intraoral Scanners, Rapid 5, Infinity 5 | 2026 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | H6000 Handpiece Cleaning and Lubrication SystemLubricant | 2010 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | DENTAL CHAIR | 2014 |
| Portable Dental Operative UnitSJH · Class 1 | — | Maker | Portable Dental Unit, PC2630, OMC2375CV, MC3600CV | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Lakong Medical Devices Co., Ltd. as the applicant.
Also lists devices cleared under other names
Lakong Medical Devices Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Lakong Medical Device Company, Ltd. (1), Tpc Advanced Technology, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Mar 2011 | K103498 | LAKONG ULTRASONIC SCALER | Lakong Medical Device Company, Ltd. | ELC Ultrasonic Scaler |
| 28 Aug 2007 | K071485 | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 | Tpc Advanced Technology, Inc. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LAKONG MEDICAL DEVICES CO., LTD.FDA reg. 3008559238 | Dongguan Guangdong, China | Foreign exporter, Manufacturer, Remanufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033552). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.