Data / Medical devices / Fixture Mount Kit
Fixture Mount Kit (NYE): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Fixture Mount Kit (product code NYE, Class 1, 21 CFR 872.3980). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NYE
- Device class
- 1
- Regulation
- 872.3980
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| South Korea | 5 |
| United States | 2 |
| China | 2 |
| Mexico | 1 |
| France | 1 |
| Ireland | 1 |
Makers of Fixture Mount Kit
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3D Diagnostix Inc | Allston, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio Concept Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| FFDM Tivoly | BOURGES CEDEX Centre-Val de Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HADER Solutions & Distribution Ltd | Swords CO Dublin Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hans Korea | Paju-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MegaGen Implant Co., Ltd. (Research Laboratories) | Daegu, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Megagen Implant Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Meierjing Medical Instrument Co., Ltd. | Zhuhai Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.