Data / Medical devices / Taiwan / Mem Dental Technology Co Ltd
Mem Dental Technology Co Ltd: FDA-registered device maker in Tainan, Taiwan, 2 510(k) clearances
Mem Dental Technology Co Ltd is registered with the FDA (registration 3009011037) in Tainan, Taiwan. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009011037
- Address
- 2F & 4F, No.22, and 2F, No. 26, Lane 31, Sec.1, Huandong Rd. Xinshi Dist., Tainan, Taiwan, 74146
- Owner or operator
- MEM DENTAL TECHNOLOGY CO LTD (10037177)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 23, 2011
- Registered through
- 2026
- Brand names listed
- Crimpable Hook, MEM Aligner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Manufacturer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Manufacturer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2025 | K242637 | MEM Clear Aligner System | NXC | Substantially Equivalent | Mem Dental Technology Co., Ltd. | accessdata.fda.gov |
| June 7, 2019 | K180952 | Ceramic Bracket | NJM | Substantially Equivalent | Mem Dental Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Orthodontic
- All makers of Plier, Orthodontic
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Band, Preformed, Orthodontic
- All makers of Bracket, Metal, Orthodontic
- All makers of Wire, Orthodontic
Updated May 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.