Denjoy Dental Co., Ltd.
Manufacturer and brand owner in Changsha, Hunan, China. 17 device types, 14 products catalogued, 1 clearance.
Denjoy Dental Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Gutta-Percha, Tester, Pulp and 15 other device types. 14 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
17device types registered with the FDA
14products catalogued under its own name
1510(k) clearance
Registration
| Registered name | DENJOY DENTAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008590661 |
| FEI number | 3008590661 |
| DUNS | 529329650 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 长沙得悦科技发展有限公司 |
|---|---|
| Source | Baike |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | F4, A4 Bld, Lugu Medical Device Park |
| Postal code | 410205 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Retractor, Dental | Class 1 | Retractor | 2011 | 37 |
| Accessory, Surgical Apparel | Class 1 | Face Shield | 2020 | 439 |
| Camera, Cine, Endoscopic, With Audio | Class 1 | Intraoral Camera | 2011 | 3 |
| Dental Prophylaxis Kit | Class 1 | Root Canal Instruments Kit | 2022 | 1 |
| Endodontic Kit | Class 2 | JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter | 2026 | 2 |
| File, Pulp Canal, Endodontic | Class 1 | Rotary File,K-File,H-File,K-Reamer | 2023 | 53 |
| Gutta-Percha | Class 1 | JAS Gutta-Percha Pellets | 2026 | 42 |
| Handpiece, Direct Drive, Ac-Powered | Class 1 | JAS Gutta-Percha Pellets, JAS Activator, JAS Ultrasonic Tips, JAS Pex, JAS Motor, JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter and 7 more | 2025 | 10 |
| Heat Source For Bleaching Teeth | Class 1 | LED Whitening Light | 2011 | 56 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class 1 | Endo Motor,endo Treatment Instrument, LOW-Voltage Electric Motor | 2011 | 10 |
| Instruments, Dental Hand | Class 1 | Hand File, Rotary File, Endo Hand File | 2014 | 64 |
| Locator, Root Apex | Class U | JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter | 2011 | 8 |
| Microscope, Surgical, General & Plastic Surgery | Class 1 | Medical Microscope | 2020 | 11 |
| Plugger, Root Canal, Endodontic | Class 1 | JAS Gutta-Percha Pellets, JAS Activator, JAS Ultrasonic Tips, JAS Pex, JAS Motor, JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter and 10 more | 2016 | 19 |
| Scaler, Ultrasonic | Class 2 | JAS Gutta-Percha Pellets, JAS Activator, JAS Ultrasonic Tips, JAS Pex, JAS Motor, JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter and 7 more | 2025 | 14 |
| Tester, Pulp | Class 2 | Pulp Tester | 2016 | 2 |
| Unit, Operative Dental, Accessories | Class 1 | Dental Suction Unit | 2022 | 65 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Endo Motor | KIJ | 6 |
| Medical Microscope | FSO | 3 |
| Integrated Endo System | EKR | 2 |
| Medical Face Shield | LYU | 1 |
| Pulp Canal Reamer | DZN | 1 |
| Intraoral Camera | FTS | 1 |
| Root Canal Instruments Kit | NYC | 1 |
| Cordless Gutta percha obturation system | EKR | 1 |
| Dental Suction Unit | NRD | 1 |
| Endo Rotary file | DZN | 1 |
| Oral retractor | EIF | 1 |
| Pulp Tester | EAT | 1 |
| Gutta Percha Cutter | EKR | 1 |
| Gutta percha obturation system | EKR | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242317 | 2025-02-13 | ELC | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 51-200 |
| Main products | Apex locators, Electric motors, Pulp testers, Rotary files, Endodontic equipment |
| Export markets | Global |
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.