Pink CAD/CAM Disc
PINK CAD/CAM disc PINK-20-98,5-SHOULDER
14manufacturers in China registered for this device type
85catalogue numbers in this listing
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 | Polident d.o.o. |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| 510(k) | K153546 |
| Record published | 2024-10-17 |
| Record revised | 2024-10-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: keep out of sunlight |
| Packaging | Carton box, plastic card |
| Sizes | Outer diameter 3 m |
| Distribution end date | 2026-04-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PMMP.1023 | In distribution | |
| PMMP.1014 | In distribution | |
| PMMP.785 | In distribution | |
| PMMPML.1049 | In distribution | |
| PMMP.511 | In distribution | |
| PMMP.1012 | In distribution | |
| PMMPML.1047 | In distribution | |
| PMMPML.993 | In distribution | |
| PMMPML.995 | In distribution | |
| PMMP.1009 | In distribution | |
| PMMP.788 | In distribution | |
| PMMPML.1035 | In distribution | |
| PMMP.784 | In distribution | |
| PMMP.489 | In distribution | |
| PMMP.1013 | In distribution | |
| PMMPML.1032 | In distribution | |
| PMMPML.996 | In distribution | |
| PMMP.783 | In distribution | |
| PMMPML.997 | In distribution | |
| PMMPML.1037 | In distribution | |
| PMMP.675 | In distribution | |
| PMMP.679 | In distribution | |
| PMMPML.1048 | In distribution | |
| PMMP.490 | In distribution | |
| PMMP.678 | In distribution | |
| PMMP.662 | In distribution | |
| PMMP.677 | In distribution | |
| PMMP.1015 | In distribution | |
| PMMP.1020 | In distribution | |
| PMMPML.1051 | In distribution | |
| PMMPML.1033 | In distribution | |
| PMMP.660 | In distribution | |
| PMMPML.1040 | In distribution | |
| PMMPML.1027 | In distribution | |
| PMMP.1025 | In distribution | |
| PMMPML.357 | In distribution | |
| PMMPML.1029 | In distribution | |
| PMMPML.1043 | In distribution | |
| PMMPML.1044 | In distribution | |
| PMMP.481 | In distribution | |
| PMMP.483 | In distribution | |
| PMMP.1016 | In distribution | |
| PMMPML.1038 | In distribution | |
| PMMP.1010 | In distribution | |
| PMMP.1018 | In distribution | |
| PMMP.787 | In distribution | |
| PMMP.1019 | In distribution | |
| PMMPML.1031 | In distribution | |
| PMMPML.1046 | In distribution | |
| PMMPML.1034 | In distribution | |
| PMMPML.1041 | In distribution | |
| PMMP.1017 | In distribution | |
| PMMPML.998 | In distribution | |
| PMMPML.1042 | In distribution | |
| PMMPML.1028 | In distribution | |
| PMMPML.356 | In distribution | |
| PMMPML.1039 | In distribution | |
| PMMP.1021 | In distribution | |
| PMMP.786 | In distribution | |
| PMMP.1022 | In distribution | |
| PMMPML.1026 | In distribution | |
| PMMPML.1036 | In distribution | |
| PMMPML.994 | In distribution | |
| PMMP.488 | In distribution | |
| PMMP.1011 | In distribution | |
| PMMPML.1050 | In distribution | |
| PMMP.1024 | In distribution | |
| PMMPML.1053 | In distribution | |
| PMMPML.1030 | In distribution | |
| PMMPML.1052 | In distribution | |
| PMMPML.1045 | In distribution | |
| PMMP.482 | In distribution | |
| PMMP.488 | Outer Diameter 3 m | Withdrawn |
| PMMP.660 | Outer Diameter 3 m | Withdrawn |
| PMMP.489 | Outer Diameter 3 m | Withdrawn |
| PMMP.487 | Outer Diameter 3 m | Withdrawn |
| PMMP.484 | Outer Diameter 3 m | Withdrawn |
| PMMP.679 | Size text | Withdrawn |
| PMMP.485 | Outer Diameter 3 m | Withdrawn |
| PMMP.662 | Outer Diameter 3 m | Withdrawn |
| PMMP.482 | Outer Diameter 3 m | Withdrawn |
| PMMP.486 | Size text | Withdrawn |
| PMMP.481 | Outer Diameter 3 m | Withdrawn |
| PMMP.490 | Size text | Withdrawn |
| PMMP.483 | Size text | Withdrawn |
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
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.