Data / Medical devices / Material, External Aesthetic Restoration, No Adhesive
Material, External Aesthetic Restoration, No Adhesive (NOK): 10 FDA-registered makers in 7 countries
10 establishments in 7 countries are registered with the FDA to make Material, External Aesthetic Restoration, No Adhesive (product code NOK, Class 1, 21 CFR 878.3800). 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
- NOK
- Device class
- 1
- Regulation
- 878.3800
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
| Taiwan | 1 |
| Dominican Republic | 1 |
| Mexico | 1 |
| Hong Kong | 1 |
| South Africa | 1 |
Makers of Material, External Aesthetic Restoration, No Adhesive
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 |
|---|---|---|---|---|---|---|---|---|
| Acro Biomedical Co., Ltd. | Kaohsiung, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BECON MEDICAL Ltd. | Batavia, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dianceht, S.A De C.V. | Tlajomulco de Zuniga Jalisco, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EarGear LLC | Eden Prairie, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Regal Prosthesis Limited | Kwai Chung NT, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riton 3D Technology Co., Ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southern Implants (pty) Ltd | IRENE Gauteng, South Africa | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Laixin 3D Technology Co.,ltd | Suzhou Jiangsu, 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.