Manufacturer registered with FDA
Hangzhou Wise Medical Device Co.,Ltd
Hangzhou, China. Lists 24 dental device types with FDA across 1 registered establishment.
- Device types listed
- 24
- Brands and models
- 24
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Hangzhou Wise Medical Device 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 Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Retainer, Screw Expansion Orthodontic | 2025 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Maintainer, Space Preformed, Orthodontic | 2025 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Wire | 2025 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Tube | 2025 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Micro screw drive handles, Orthodontic Tools, Self-ligation Tools | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mirrors Mouth Orthodontic (all types of Orthodontic Mirror Glass and Stainless steel) | 2025 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Dental Operating Light (lamp) | 2025 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Band | 2025 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Spring, Orthodontic | 2025 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Orthodotnic Elastics, Orthodontic Hooks, Aligner Chewies, Retainer Retrievers, Invisible Braces Box (ALIGNER BOX) | 2025 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Wax, Dental | 2025 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Polishing Strip | 2025 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Retractor Orthodontic (All Type retractors) | 2025 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Bracket, Lingual Button | 2025 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Bur, Dental | 2025 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Matrices Refill Sectional contoured metal | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | File, Pulp canal | 2025 |
| Preformed CrownELZ · Class 1 | — | Maker | Dental crown | 2025 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Plier | 2025 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | Facebow | 2025 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Positioner Tooth Preformed | 2025 |
| Acacia and Karaya with Sodium Borate Denture AdhesiveKOM · Class 1 | — | Maker | Adhesive, Denture (All types) | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Accessories, lmplant, Dental, Endosseous, Dental Implant Torque Wrench | 2025 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | Patient personal hygiene kit | 2025 |
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 WISE MEDICAL DEVICE CO.,LTDFDA reg. 3043149181 | Hangzhou Zhejiang, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094837). 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.