Data / Medical devices / China / Shenzhen Rogin Medical Co., Ltd
Shenzhen Rogin Medical Co., Ltd: FDA-registered device maker in shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Rogin Medical Co., Ltd is registered with the FDA (registration 3015136927) in shenzhen Guangdong, China. It lists 51 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015136927
- Address
- Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist, shenzhen Guangdong, China, 518129
- Owner or operator
- SHENZHEN ROGIN MEDICAL CO., LTD (10058732)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 24, 2018
- Registered through
- 2026
- Brand names listed
- (dental)needle, Root Canal Irrigation Needle, Absorbent Paper Points, Apex Locator, Arch Wire/Straight Wires, Barbed Broaches, Barbed Broaches, Buccal Tubes/, Ceramic Bracket/, DIAMOND BURS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Accessories, Retractor, Dental | EIF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Articulators | EJP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bone Particle Collector | MXP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Broach, Endodontic | EKW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Burnisher, Operative | EKJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dermatome | GFD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Epilator, High Frequency, Tweezer-Type | KCX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Contouring, Matrix, Operative | EKF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Loupe, Diagnostic/Surgical | FSP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Microscope, Surgical | EPT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Suction Operatory | EBR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2025 | K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | EKX | Substantially Equivalent | Shenzhen Rogin Medical Co., Ltd. | accessdata.fda.gov |
| March 7, 2025 | K242383 | Apex Locator | LQY | Substantially Equivalent | Shenzhen Rogin Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dermatome
- All makers of Disinfector, Medical Devices
- All makers of Evacuator, Oral Cavity
- All makers of Post, Root Canal
- All makers of Band, Elastic, Orthodontic
- All makers of Articulators
Updated April 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.