Manufacturer registered with FDA
Hangzhou Orthmay Advanced Materials Technology Co., Ltd
Hangzhou City, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 46
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Hangzhou Orthmay Advanced Materials Technology 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 Wire | 2023 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | B103-21 Bondable 1st Convertible Slot 022 Edgewise Buccal Tube;B104-11 Bondable 1st Non-Convertible Slot 018 Edgewise Buccal Tube;B104-21 Bondable 1st Non-Convertible Slot 022 Edgewise Buccal Tube;B106-21 Weldable 1st Non-Convertible Slot 022 Roth Buccal Tube;B107-21 Bondable 1st Convertible Slot 022 Roth Buccal Tube;B108-11 Bondable 1st Non-Convertible Slot 018 Roth Buccal Tube;B108-21 Bondable 1st Non-Convertible Slot 022 Roth Buccal Tube;B110-21 Weldable 1st Non-Convertible Slot 022 MBT Buccal Tube;B111-21 Bondable 1st Convertible Slot 022 MBT Buccal Tube;B112-11 Bondable 1st Non-Convertible Slot 018 MBT Buccal Tube; 8 moreB112-21 Bondable 1st Non-Convertible Slot 022 MBT Buccal Tube;B204-11 Bondable 2nd Non-Convertible Slot 018 Edgewise Buccal Tube;B204-21 Bondable 2nd Non-Convertible Slot 022 Edgewise Buccal Tube;B208-11 Bondable 2nd Non-Convertible Slot 018 Roth Buccal Tube;B208-21 Bondable 2nd Non-Convertible Slot 022 Roth Buccal Tube;B212-11 Bondable 2nd Non-Convertible Slot 018 MBT Buccal TubeB212-21 Bondable 2nd Non-Convertible Slot 022 MBT Buccal Tube.Orthodontic Tube (B102-21 Weldable 1st Non-Convertible Slot 022 Edgewise Buccal Tube; | 2023 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Band | 2023 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | G140-00 Power Chain Closed, G200-00 Rotation Wedges, G150-00 Intraoral Elastic 2.5oz; G160-00 Intraoral Elastic 3.5oz,G170-00 Intraoral Elastic 4.5oz, G180-00 Intraoral Elastic 6.5oz, G190-00 Separator.Orthodotnic Elastics, Orthodontic Hooks; G110-00 Ligature Tie, G120-00 Power Chain Long, G130-00 Power Chain Short, | 2023 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | A104-21 Monoblock Mini with hook on 3,4,5 Slot 022 Edgewise Bracket;A108-21 Monoblock Mini with hook on 3,4,5 Slot 022 Roth Bracket;A116-21 Monoblock Mini with hook on 3,4,5 Slot 022 MBT Bracket;A120-21 Monoblock Mini with hook on 3,4,5 Slot 022 MBT Self Ligating Bracket;A202-21 Bondable Standard with hook on 3,4,5 Slot 022 Edgewise Bracket;A203-21 Bondable Mini No Hook Slot 022 Edgewise Bracket;A204-11 Bondable Mini with hook on 3,4,5 Slot 018 Edgewise Bracket;A204-21 Bondable Mini with hook on 3,4,5 Slot 022 Edgewise Bracket;A205-21 Bondable Standard No Hook Slot 022 Roth Bracket;A206-21 Bondable Standard with hook on 3,4,5 Slot 022 Roth Bracket; 12 moreA207-21 Bondable Mini No Hook Slot 022 Roth Bracket;A208-11 Bondable Mini with hook on 3,4,5 Slot 018 Roth Bracket;A208-21 Bondable Mini with hook on 3,4,5 Slot 022 Roth Bracket;A210-21 Bondable Standard with hook on 3,4,5 Slot 022 Roth Self Ligating Bracket;A212-21 Bondable Mini with hook on 3,4,5 Slot 022 Roth Self Ligating Bracket;A213-21 Bondable Standard No Hook Slot 022 MBT Bracket;A214-21 Bondable Standard with hook on 3,4,5 Slot 022 MBT Bracket;A215-21 Bondable Mini No Hook Slot 022 MBT Bracket;A216-21 Bondable Mini with hook on 3,4,5 Slot 022 MBT Bracket;A218-21 Bondable Standard with hook on 3,4,5 Slot 022 MBT Self Ligating Bracket;A220-21 Bondable Mini with hook on 3,4,5 Slot 022 MBT Self Ligating Bracket.Orthodontic Bracket, Lingual Button; | 2023 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Plier | 2023 |
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 ORTHMAY ADVANCED MATERIALS TECHNOLOGY CO., LTDFDA reg. 3027323119 | Hangzhou City Zhejiang, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087622). 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.