Basis Flow II
Basis Flow II is a self-curing acrylic for fabricating or repairing denture bases. It is supplied as a PMMA polymer powder and a methyl methacrylate liquid. Mixing produces a dough that is…
Basis Flow II is a self-curing acrylic for fabricating or repairing denture bases. It is supplied as a PMMA polymer powder and a methyl methacrylate liquid. Mixing produces a dough that is poured or packed into a mould, saddle or core before curing.
The powder includes initiator and pigments, while the liquid contains cross-linking agent and activator. The material forms the gum portion of dentures and can also form the plate portion of orthodontic appliances. It cures using a pressure-vessel or quick-setting process.
Material Type
The product is a pouring acrylic rather than a prefabricated denture base. The described material meets denture-base polymer and orthodontic-base polymer classifications. Compared with the earlier Basis Flow formulation, the change is addition of a polymerization inhibitor to the components.
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) | K233859 |
| Record published | 2023-09-29 |
| Record revised | 2024-03-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 500G,CLEAR | In distribution | |
| 500G,V PINK | In distribution | |
| 500G,LF α | In distribution | |
| 500G,O PINK | In distribution | |
| 40G*20ML,O PINK | In distribution | |
| 20ML | In distribution | |
| 10KG,LF PINK | In distribution | |
| 650G*500ML,LF α | In distribution | |
| 10KG,CLEAR | In distribution | |
| 10KG,O PINK | In distribution | |
| 4L | In distribution | |
| 40G*20ML,LF PINK | In distribution | |
| 650G*500ML,LF PINK | In distribution | |
| 650G*500ML,O PINK | In distribution | |
| 40G,V PINK | In distribution | |
| 500G,LF PINK | In distribution | |
| 40G*20ML,V PINK | In distribution | |
| 40G,LF PINK | In distribution | |
| 10KG,V PINK | In distribution | |
| 40G,O PINK | In distribution | |
| 40G,LF α | In distribution | |
| 17L | In distribution | |
| 500ML | In distribution | |
| 40G*20ML,LF α | In distribution | |
| 40G*20ML,CLEAR | In distribution | |
| 650G*500ML,CLEAR | In distribution | |
| 650G*500ML,V PINK | In distribution | |
| 40G,CLEAR | In distribution | |
| 10KG,LF α | 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.