Manufacturer registered with FDA
Yamahachi Dental Mfg. Co.
Gamagori City, Japan. Lists 9 dental device types with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 28
- 510(k) clearances
- 32018–2026
- Markets registered in
- 1056,137 registrations outside the US
- Establishments
- 2China, Japan
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Yamahachi Dental Mfg. Co. 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 | Yamahachi Dental Mfg. Co. | 3 clearances | 2018–2026 | Below |
| European Union | EUDAMED | Manufacturer | YAMAHACHI DENTAL MFG., CO. | 56,011 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | YAMAHACHI DENTAL MFG, CO | 72 | 2007–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | YAMAHACHI DENTAL MFG., CO.YAMAHACHI DENTAL MFG CO | 17 | 2005–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | YAMAHACHI DENTAL MFG., CO. | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | YAMAHACHI DENTAL MFG., CO.YAMAHACHI DENTAL MFG., Co. | 11 | 2013–2022 | Pure Global AI |
| South Korea | MFDS | Manufacturer | YAMAHACHI DENTAL MFG. COYAMAHACHI DENTAL MFG., LTD · YAMAHACHI DENTAL MFG CO · +2 | 7 | 1999–2011 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | YAMAHACHI DENTAL MFG., CO. | 3 | 2024–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Yamahachi Dental Mfg Co | 2 | 2026–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | YAMAHACHI DENTAL MFG CO | 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 Yamahachi Dental Mfg. Co. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | BasisBASIS FLOW IIBasis HiBasis Twin CureJUSTI PRODUCTS OEM DISKRefine BrightWeldenzYamahachi Pink CAD/CAM Disk | 2013 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Crown NS Efucera NSCrown PXEfucera ACEfucera PXFlat ACNaperceNew AceShade GuideSoluut PX | 2008 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | GLOSSY COAT | 2026 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Yamahachi PMMA Disks | 2015 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Light Resin PlateTrinDy TrayTrinDy Try-In | 2022 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Bite Rim SticksWAX DISKYamahachi Parafin Wax | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | TrinDy Surgical Guide | 2026 |
| Preformed ClaspEHP · Class 1 | — | Maker | Weldenz | 2013 |
| Preformed CrownELZ · Class 1 | — | Maker | Weldenz | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Yamahachi Dental Mfg. Co. as the applicant, including filings under its other names.
Also lists devices cleared under other names
Yamahachi Dental Mfg. Co. 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: Yamahachi Dental Products USA, Inc. (1), Yamahachi Dental Manufacturing Co. (1), Unix-Japan Co., Ltd. (1), Valplast Intl. Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Nov 2015 | K151764 | YAMAHACHI PMMA DISKS | Yamahachi Dental Products USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 12 Jul 2013 | K131036 | YAMAHACHI DENTURE BASE RESINS | Yamahachi Dental Manufacturing Co. | EBI Rebasing Repairing Relining Denture Resin |
| 18 Nov 2011 | K111709 | FOUNDATION DENTAL RESIN | Unix-Japan Co., Ltd. | EBI Rebasing Repairing Relining Denture Resin |
| 7 Apr 2006 | K060507 | VALPLAST YAMAHACHI TEETH | Valplast Intl. Corp. | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Yamahachi Dental Material (Changshu) Co., Ltd.FDA reg. 3006942327 | Changshu city Jiangsu, China | Manufacturer |
| YAMAHACHI DENTAL MFG. CO.FDA reg. 3020841418 | Gamagori City Aichi, Japan | Complaint file establishment, Manufacturer, Specification developer |
Other names on FDA records
Yamahachi Dental Material (Changshu) Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024459). 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.