Manufacturer registered with FDA
Mem Dental Technology Co., Ltd.
Tainan, Taiwan. Lists 10 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 10
- Brands and models
- 2
- 510(k) clearances
- 22019–2025
- Markets registered in
- 614 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Mem Dental Technology 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 | Mem Dental Technology Co., Ltd. | 2 clearances | 2019–2025 | Below |
| South Korea | MFDS | Manufacturer | MEM Dental Technology Co., Ltd.MEM Dental Technology Co., Ltd · MEM Dental Technology Co.,Ltd | 6 | 2013–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | MEM Dental Technology Co., Ltd | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | MEM Dental Technology Co., Ltd | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | MEM Dental Technology Co Ltd | 1 | 2023–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MEM DENTAL TECHNOLOGY CO., LTD. | 1 | — | 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 Mem Dental 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 | — | 2011 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | — | 2011 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | — | 2011 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | — | 2014 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Crimpable Hook | 2024 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | — | 2011 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | — | 2011 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | — | 2011 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | — | 2019 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | MEM Aligner | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Mem Dental Technology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 May 2025 | K242637 | MEM Clear Aligner System | NXC Sequential Aligner |
| 7 Jun 2019 | K180952 | Ceramic Bracket | NJM Orthodontic Ceramic Bracket |
Some of these clearances are listed with FDA today by another company: Ortho Attachyhook Supply LTD. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEM DENTAL TECHNOLOGY CO LTDFDA reg. 3009011037 | Tainan, Taiwan | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10037177). 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.