Yamahachi Pink CAD/CAM Disk
Yamahachi Pink CAD/CAM Disk is an acrylic blank for milling dentures. Professional dental technicians use it within compatible CAD/CAM systems to produce a restoration from a digital…
Yamahachi Pink CAD/CAM Disk is an acrylic blank for milling dentures. Professional dental technicians use it within compatible CAD/CAM systems to produce a restoration from a digital design.
The solid disk is made from heat-cured, crosslinked polymethyl methacrylate with pigments. Different shapes, dimensions and shades accommodate the milling equipment and denture design.
Milling Compatibility
Circular disks serve open milling systems, while other configurations support specified closed systems such as Amann Girrbach and Zirkonzahn or compatible block milling. The blank supplies the restorative material; scanning equipment, design software and milling machinery are separate parts of the workflow.
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Yamahachi Dental MFG. Co., Japan |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K172683 |
| Record published | 2021-04-10 |
| Record revised | 2026-02-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98.5mm*35mm, A3+V PINK | In distribution | |
| 95mm*20mm, V PINK | In distribution | |
| 98.5mm*35mm, A3.5+V PINK | In distribution | |
| 98.5mm*30mm, V PINK | In distribution | |
| 98.5mm*35mm, V PINK | In distribution | |
| 98.5mm*35mm, A2+V PINK | In distribution | |
| 98.5mm*35mm, A1+V PINK | In distribution | |
| 98.5mm*35mm, B2+V PINK | In distribution | |
| 98.5mm*35mm, C2+V PINK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Nobilium | Cmp Industries, LLC | 167 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Unbreakable by TCS | Thermoplastic Comfort SYS | 96 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233859 | 2024-03-05 |
| K172683 | 2018-01-16 |
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.