Manufacturer registered with FDA
Zhongshan Xinhe Co.,Ltd
Zhongshan City, China. Lists 15 dental device types with FDA across 0 registered establishments.
- Device types listed
- 15
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 0—
Devices listed with FDA
What Zhongshan Xinhe 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 WireDZC · Class 1 | Orthodontic wires & bands | Maker | Wire, Orthodontic | 2026 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Hand Driver, Lab Driver, Multi Unit Hes Driver, Torque Wrench, Locator Core Tool, Implant Drive, Chewing Gum,Torque Wrench, Locator Core Tool | 2026 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mirror, Mouth | 2026 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Unit, Oral Irrigation | 2026 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush, Manual | 2026 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Remover, Crown | 2026 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Instrument, Filling, Plastic, Dental | 2026 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Bur, Dental | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta-percha | 2026 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Point, Paper, Endodontic | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | File, Pulp Canal, Endodontic | 2026 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Scaler, Periodontic | 2026 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Toothbrush, Powered | 2026 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss, Dental | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Healing Cap, Hand Driver, Lab hex Driver, Multi-Unit Hex Driver, Torque Wrench, Locator-Core Tool, Cover CapLab Analog, Impression Coping, Scanbody, Cover Cap, Drill Extension, Driver Adapter, Temporary Coping,Temporary Positioning Screw, Abutment Screw, Multi-Unit Screw, Implant Analog, Impression Coping, Scan Body, | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096694). 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.