Manufacturer registered with FDA
Xingyue Medical Health Technology (Nanjing) Co., Ltd .
Nanjing, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Xingyue Medical Health Technology (Nanjing) 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 |
|---|---|---|---|---|
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Protective WaxOrthodontic Rings | 2025 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Teeth Whitening Kits | 2025 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Denture&Retainer Cleanser/Tablets | 2025 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Interdental BrushesToothbrushes | 2025 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental flossOrthodontic Floss | 2025 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | Oral Care Kits | 2025 |
| Plaque Disclosing AgentQJC · Class 1 | — | Maker | plaque indicator | 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 |
|---|---|---|
| XINGYUE MEDICAL HEALTH TECHNOLOGY (NANJING) CO., LTD .FDA reg. 3035708505 | Nanjing Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092804). 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.