Manufacturer registered with FDA
Denjoy Dental Co., Ltd.
Changsha city, China. Lists 12 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 12
- Brands and models
- 45
- 510(k) clearances
- 12025–2025
- Markets registered in
- 617 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Denjoy Dental 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 | Denjoy Dental Co., Ltd. | 1 clearances | 2025–2025 | Below |
| European Union | EUDAMED | Manufacturer | DENJOY DENTAL CO., LTD | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENJOY DENTAL CO., LTD. | 4 | 2022–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENJOY DENTAL CO., LTD | 4 | 2019–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DENJOY DENTAL CO.,LTDDenjoy Dental Co.,Ltd. | 3 | 2008–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Denjoy Dental Co., Ltd. | 2 | — | 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 Denjoy Dental 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 |
|---|---|---|---|---|
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Integrated Endo System (Meet Endo-II)JAS ActivatorJAS Activator Ultrasonic TipsJAS Charging UnitJAS Contra-angleJAS FillJAS Fill Gutta-Percha NeedlesJAS Heat Plugger TipsJAS MotorJAS Pack Gutta-Percha Cutter 3 moreJAS PexJAS Power SupplyJAS Unit Endo System | 2016 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | ENDO HAND FILEHAND FILE, ROTARY FILE | 2014 |
| Pulp TesterEAT · Class 2 | — | Maker | PULP TESTER | 2016 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | LED WHITENING LIGHT | 2011 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | RETRACTOR | 2011 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | JAS Gutta-Percha Pellets | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Rotary File,K-File,H-File,K-Reamer | 2023 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Integrated Endo System (Meet Endo-II)JAS ActivatorJAS Activator Ultrasonic TipsJAS Charging UnitJAS Contra-angleJAS FillJAS Fill Gutta-Percha NeedlesJAS MotorJAS PexJAS Power Supply 1 moreJAS Unit Endo System | 2025 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Integrated Endo System (Meet Endo-II)JAS ActivatorJAS Activator Ultrasonic TipsJAS Charging UnitJAS Contra-angleJAS FillJAS Fill Gutta-Percha NeedlesJAS MotorJAS PexJAS Power Supply 1 moreJAS Unit Endo System | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Dental Suction Unit | 2022 |
| Dental Prophylaxis KitNYC · Class 1 | Dental hand instruments | Maker | Root Canal Instruments Kit | 2022 |
| Endodontic KitNYD · Class 2 | — | Maker | JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENJOY DENTAL CO., LTDFDA reg. 3008590661 | Changsha city Hunan, China | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034843). 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.