Yamahachi Dental Material (Changshu) Co., Ltd.
Registered establishment in Changshu, Jiangsu, China. 9 device types.
Yamahachi Dental Material (Changshu) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Clasp, Preformed, Crown, Preformed and 7 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006942327 |
| FEI number | 3006942327 |
| Establishment type | Manufacturer |
Location
| City | Changshu |
|---|---|
| Province | Jiangsu |
| Address | No. 8 Zhibei Road, Zhitang Town |
| Postal code | 215531 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | TrinDy Surgical Guide | 2026 | 70 |
| Clasp, Preformed | Class 1 | Weldenz | 2013 | 3 |
| Coating, Filling Material, Resin | Class 2 | Glossy Coat | 2026 | 1 |
| Crown And Bridge, Temporary, Resin | Class 2 | Yamahachi PMMA Disks | 2015 | 13 |
| Crown, Preformed | Class 1 | Weldenz | 2013 | 23 |
| Denture, Plastic, Teeth | Class 2 | Crown NS Efucera NS, Soluut PX, Crown PX, Efucera PX, Naperce, New Ace and 3 more | 2008 | 26 |
| Material, Impression Tray, Resin | Class 1 | Light Resin Plate, TrinDy Tray, TrinDy Try-In | 2022 | 41 |
| Resin, Denture, Relining, Repairing, Rebasing | Class 2 | Basis Hi, Basis Twin Cure, Refine Bright, Basis, Basis Flow II, Yamahachi Pink CAD/CAM Disk and 2 more | 2013 | 14 |
| Wax, Dental, Intraoral | Class 1 | Bite Rim Sticks, Yamahachi Parafin Wax, WAX Disk | 2016 | 55 |
Clearances
No clearance names Yamahachi Dental Material (Changshu) Co., Ltd. as applicant. 7 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254091 | 2026-04-06 | EBD | Traditional | Yamahachi Dental MFG. Co. |
| K233859 | 2024-03-05 | EBI | Traditional | Yamahachi Dental MFG. Co. |
| K172683 | 2018-01-16 | EBI | Traditional | Yamahachi Dental MFG. Co. |
| K151764 | 2015-11-23 | EBG | Traditional | Yamahachi Dental Products USA, Inc. |
| K131036 | 2013-07-12 | EBI | Traditional | Yamahachi Dental Manufacturing Co. |
| K111709 | 2011-11-18 | EBI | Traditional | Unix-Japan Co., Ltd. |
| K060507 | 2006-04-07 | ELM | Traditional | Valplast Intl. Corp. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1992 |
|---|---|
| Main products | Dental materials, Composite teeth, Denture components |
| Export markets | Global |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.