Data / Medical devices / Taiwan / COHO Advanced Materials Tech. Co., Ltd.
COHO Advanced Materials Tech. Co., Ltd.: FDA-registered device maker in Luzhu District Taoyuan, Taiwan, 2 510(k) clearances
COHO Advanced Materials Tech. Co., Ltd. is registered with the FDA (registration 3006110126) in Luzhu District Taoyuan, Taiwan. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 17, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006110126
- Address
- 21 Dafeng Street, Luzhu District Taoyuan, Taiwan, 33860
- Owner or operator
- COHO Advanced Materials Tech. Co., Ltd. (10034334)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 23, 2010
- Registered through
- 2026
- Brand names listed
- "COHO" Orthodontic appliance and accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | 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 |
|---|---|---|---|---|---|---|
| June 17, 2015 | K140836 | ZIBONE ZIRCONIA BLOCKS | EIH | Substantially Equivalent | Coho Technology Co., Ltd. | accessdata.fda.gov |
| June 4, 2014 | K132585 | ZIBONE CERAMIC DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Coho Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Blade, Scalpel
- All makers of Powder, Porcelain
- All makers of Crown, Preformed
Updated June 17, 2015. 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.