Manufacturer registered with FDA
COHO Advanced Materials Tech. Co., Ltd.
Luzhu District, Taiwan. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Taiwan
Registered in 2 markets
Where regulators' registries name COHO Advanced Materials Tech. 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 | COHO Advanced Materials Tech. Co., Ltd. | 7 device types | — | Below |
| China | NMPA | Registration holder | 光弘精材科技股份有限公司COHO Advanced Materials Tech. 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 COHO Advanced Materials Tech. 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | — | 2010 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | "COHO" Orthodontic appliance and accessories | 2022 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2014 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | — | 2015 |
| Preformed CrownELZ · Class 1 | — | Maker | — | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
COHO Advanced Materials Tech. Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Coho Technology Co., Ltd. (1), Coho Technology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Jun 2015 | K140836 | ZIBONE ZIRCONIA BLOCKS | Coho Technology Co., Ltd. | EIH Porcelain Powder |
| 4 Jun 2014 | K132585 | ZIBONE CERAMIC DENTAL IMPLANT SYSTEM | Coho Technology Co., Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| COHO Advanced Materials Tech. Co., Ltd.FDA reg. 3006110126 | Luzhu District Taoyuan, Taiwan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034334). 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.