Manufacturer registered with FDA
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd
Hangzhou, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Hangzhou Xingchen 3B Dental Instrument & Materials 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 | Hangzhou Xingchen 3B Dental Instrument & Material Co., Ltd. | 2015 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Hangzhou 3B | 2012 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Ortho Elastics | 2024 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | hangzhou 3B | 2012 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | hangzhou 3B | 2012 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | hangzhou 3B | 2012 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | Hangzhou Xingchen 3B Dental Instrument & Material Co., Ltd. | 2015 |
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 |
|---|---|---|
| HANGZHOU XINGCHEN 3B DENTAL INSTRUMENT & MATERIALS CO., LTDFDA reg. 3009646973 | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040829). 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.