Manufacturer registered with FDA
Ningbo Denrotary Medical Apparatus Co., Ltd.
Ningbo City, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Ningbo Denrotary Medical Apparatus 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 | Ningbo Denrotary Medical Apparatus Co., Ltd. | 9 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Ningbo Denrotary Medical Apparatus Co., Ltd. | 4 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NINGBO DENROTARY MEDICAL APPARATUS CO. , LTD | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Ningbo Denrotary Medical Apparatus Co., Ltd. | 1 | 2025–2025 | 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 Ningbo Denrotary Medical Apparatus 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 | orthodontic wires | 2026 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | orthodontic buccal tube | 2026 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Retainer Case | 2026 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | ligature tie orthodontics/orthodontic elastic rubber bands/power chain/Orthodontic Elastic Band/Orthodontic Appliance and Accessories | 2026 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | molar bands | 2026 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Crimpable hook, Remover Hook | 2026 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | aligner chewies | 2026 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | orthodontic brackets/lingual button | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Endodontic File | 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 |
|---|---|---|
| NINGBO DENROTARY MEDICAL APPARATUS CO., LTD.FDA reg. 3049836324 | Ningbo City Zhejiang, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096220). 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.