Yamahachi Pink CAD/CAM Disk (Justi)
Yamahachi Pink CAD/CAM Disk is a pigmented acrylic blank milled into dentures by professional dental technicians. The material is hot-cured, cross-linked polymethyl methacrylate, or PMMA. A…
Yamahachi Pink CAD/CAM Disk is a pigmented acrylic blank milled into dentures by professional dental technicians. The material is hot-cured, cross-linked polymethyl methacrylate, or PMMA.
A CAD/CAM milling machine carves the restoration from the blank according to a digital design. The disk is the fabrication material; scanning equipment, design software and the milling machine are separate parts of the workflow.
Milling Formats
The range varies in shade, shape, diameter, thickness and profile margin. Circular disks serve open milling systems, while other configurations fit specified closed systems such as Amann Girrbach and Zirkonzahn. Block-type use requires an appropriate, compatible CAM system and milling machine.
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 | 2019-08-05 |
| 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 |
|---|---|---|
| 30mm, ORIGINAL | In distribution | |
| 30mm, DARK PINK | In distribution | |
| 30mm, LIGHT | In distribution | |
| 25mm, ORIGINAL | In distribution | |
| 20mm, DARK PINK | In distribution | |
| 25mm, DARK PINK | In distribution | |
| 20mm, LIGHT REDDISH PINK | In distribution | |
| 30mm, LIGHT REDDISH PINK | In distribution | |
| 25mm, LIGHT | In distribution | |
| 25mm, LIGHT REDDISH PINK | In distribution | |
| 20mm, ORIGINAL | In distribution | |
| 20mm, LIGHT | 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.