Manufacturer registered with FDA
Elung Industrial Co.ltd.
T.S.T.,KOWLOON, HONG KONG, China. Lists 3 dental device types with FDA across 3 registered establishments.
- Device types listed
- 3
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 3China
Registered in 2 markets
Where regulators' registries name Elung Industrial 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 | Elung Industrial Co.ltd. | 3 device types | — | Below |
| Colombia | INVIMA | Manufacturer | ELUNG INDUSTRIAL COMPANY.LTD. | 3 | — | 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 Elung Industrial 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 |
|---|---|---|---|---|
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | Gel SoothersIce Gel SoothersIce Gel TeethersWater Filled Cooling Gum Soother | 2009 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Maker | LUV N'CARENON-FLUID FILLEDNUBYPARENT'S CHOICERINGTEETHING | 2006 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | TOOTHBRUSH | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Elung Industrial 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: Luv N' Care, Ltd. (1), Corium Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Mar 2010 | K092494 | GEL FILLED GUM SOOTHER | Luv N' Care, Ltd. | KKO Fluid-Filled Teething Ring |
| 16 Jun 1998 | K981202 | WATER FILLED GUM SOOTHER | Corium Corp. | KKO Fluid-Filled Teething Ring |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Dongguan Qing Xi Essentia Industries LtdFDA reg. 3010626066 | Dongguan Guangdong, China | Manufacturer |
| ELUNG INDUSTRIAL CO.LTD.FDA reg. 3006610790 | T.S.T.,KOWLOON, HONG KONG, China | Foreign exporter |
| SHANTOU CHAONAN LIANGYING HEGAO PLASTIC TOY FACTORYFDA reg. 3008191511 | SHANTOU Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Other names on FDA records
Dongguan Qing Xi Essentia Industries Ltd · Shantou Chaonan Liangying Hegao Plastic Toy Factory
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052953). 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.