Premium Powder
Heat Processed Denture Acrylic Resin Powder
14manufacturers in China registered for this device type
31catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Lang Dental Manufacturing Co., Inc., United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Premarket notification | Exempt |
| Record published | 2017-12-01 |
| Record revised | 2021-11-10 (version 4) |
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 |
|---|---|---|
| 45.4 KG CLEAR | In distribution | |
| 11.3 KG CLEAR | In distribution | |
| 45.4 KG BOX CLEAR | In distribution | |
| 45.4 KG FIBRED PINK | In distribution | |
| 45.4 KG BOX MEHARRY | In distribution | |
| 2.3 KG MEHARRY | In distribution | |
| 2.3 KG CHERI FIBRED PINK | In distribution | |
| 454 GRAM CP21 | In distribution | |
| 11.3 KG MEHARRY | In distribution | |
| 45.4 KG CHERI FIBRED PINK | In distribution | |
| 11.3 KG CHERI FIBRED PINK | In distribution | |
| 454 GRAM MEHARRY | In distribution | |
| 45.4 KG BOX PINK | In distribution | |
| 454 GRAM FIBRED PINK | In distribution | |
| 11.3 KG CP21 | In distribution | |
| 45.4 KG BOX CP21 | In distribution | |
| 2.3 KG PINK | In distribution | |
| 454 GRAM CLEAR | In distribution | |
| 45.4 KG PINK | In distribution | |
| 2.3 KG CLEAR | In distribution | |
| 45.4 KG BOX CHERI FIBRED PINK | In distribution | |
| 45.4 KG CP21 | In distribution | |
| 11.3 KG PINK | In distribution | |
| 11.3 KG CP21 NO FIBERS | In distribution | |
| 2.3 KG CP21 | In distribution | |
| 2.3 KG FIBRED PINK | In distribution | |
| 454 GRAM CHERI FIBRED PINK | In distribution | |
| 45.4 KG MEHARRY | In distribution | |
| 11.3 KG FIBRED PINK | In distribution | |
| 454 GRAM PINK | In distribution | |
| 45.4 KG BOX FIBRED 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 |
|---|---|
| K163482 | 2017-05-31 |
| K152981 | 2016-09-02 |
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.