Perflex Biosens
Box of 6 Large cartridges 25mm diameter and 98mm long, 28Gr. net of thermoplastic Biosens Standard Pink filled inside of each cartridge sealed in aluminum bag, The cartridges are suitable…
Box of 6 Large cartridges 25mm diameter and 98mm long, 28Gr. net of thermoplastic Biosens Standard Pink filled inside of each cartridge sealed in aluminum bag, The cartridges are suitable for 25mm size thermoplastic injectors machines.
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 | Perflex Ltd, Israel |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K150454 |
| Record published | 2017-03-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Transparent Clear 1kg jar | In distribution | |
| Light Pink Clear 1kg jar | In distribution | |
| Light Pink1kg jar | In distribution | |
| Light Pink 200gr. jar | In distribution | |
| Cartridge STD Pink Medium 25mm | In distribution | |
| Light Pink Clear 200gr. jar | In distribution | |
| Standard Pink Clear 200gr. jar | In distribution | |
| Transparent Clear 200gr. jar | In distribution | |
| Cartridge STD Pink Large 25mm | In distribution | |
| Light Dark Mahari 1kg jar | In distribution | |
| Standard Pink Clear 1kg jar | In distribution | |
| Opaque Pink1kg jar | In distribution | |
| Standard Pink 200gr. jar | In distribution | |
| Purple Pink 200gr. jar | In distribution | |
| Opaque Pink 200gr. jar | In distribution | |
| Light Dark Mahari 200gr. jar | In distribution | |
| Standard Pink | In distribution | |
| Purple Pink 1kg jar | 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 |
|---|---|
| K150454 | 2015-05-26 |
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.