Data / Medical devices / China / Yamahachi Dental Material (Changshu) Co., Ltd.
Yamahachi Dental Material (Changshu) Co., Ltd.: FDA-registered device maker in Changshu city Jiangsu, China, 7 510(k) clearances
Yamahachi Dental Material (Changshu) Co., Ltd. is registered with the FDA (registration 3006942327) in Changshu city Jiangsu, China. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006942327
- Address
- No. 8 Zhibei Road, Zhitang Town, Changshu city Jiangsu, China, 215531
- Owner or operator
- Yamahachi Dental Mfg. Co. (10024459)
- Roles
- Manufacturer
- First device listed
- February 3, 2008
- Registered through
- 2026
- Brand names listed
- BASIS FLOW II, Basis, Basis Hi, Basis Twin Cure, Bite Rim Sticks, Crown NS Efucera NS, Crown PX, Efucera AC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Clasp, Preformed | EHP | 1 | Manufacturer | accessdata.fda.gov |
| Coating, Filling Material, Resin | EBD | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 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 |
|---|---|---|---|---|---|---|
| April 6, 2026 | K254091 | GLOSSY COAT (15ML) | EBD | Substantially Equivalent | YAMAHACHI DENTAL MFG., Co. | accessdata.fda.gov |
| March 5, 2024 | K233859 | BASIS FLOW II | EBI | Substantially Equivalent | YAMAHACHI DENTAL MFG., Co. | accessdata.fda.gov |
| January 16, 2018 | K172683 | Yamahachi Pink CAD/CAM Disk | EBI | Substantially Equivalent | YAMAHACHI DENTAL MFG., Co. | accessdata.fda.gov |
| November 23, 2015 | K151764 | YAMAHACHI PMMA DISKS | EBG | Substantially Equivalent | Yamahachi Dental Products USA, Inc. | accessdata.fda.gov |
| July 12, 2013 | K131036 | YAMAHACHI DENTURE BASE RESINS | EBI | Substantially Equivalent | Yamahachi Dental Manufacturing Co. | accessdata.fda.gov |
| November 18, 2011 | K111709 | FOUNDATION DENTAL RESIN | EBI | Substantially Equivalent | Unix-Japan Co., Ltd. | accessdata.fda.gov |
| April 7, 2006 | K060507 | VALPLAST YAMAHACHI TEETH | ELM | Substantially Equivalent | Valplast Intl. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Material, Impression Tray, Resin
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Denture, Plastic, Teeth
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Crown, Preformed
Updated April 6, 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.