P Pro Crown & Bridge A1
P pro Crown & Bridge is a flowable, light-curing composite used to manufacture temporary dental restorations by an additive process. It supports anterior and posterior applications,…
P pro Crown & Bridge is a flowable, light-curing composite used to manufacture temporary dental restorations by an additive process. It supports anterior and posterior applications, including single crowns, veneers, inlays and onlays.
The acrylate-based material contains multifunctional acrylic resins and inorganic fillers. Light exposure polymerizes the material into the form of the planned temporary restoration.
Listed Item
P pro Crown & Bridge A1 1000g
Bridge Limits
Temporary bridges are limited to six units with no more than two consecutive pontics. The material is intended for contact with the gums, enamel and dentin during temporary restoration use; the listed presentation is the A1 shade.
Who Else Makes It
Concentrated in Guangdong (5), Shandong (2), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Showing 12 of 13. All 13 manufacturers in China registered for Crown And Bridge, Temporary, Resin
Record
| Listed by | Deltamed Gmbh, Germany |
|---|---|
| FDA product code | EBG |
| Device type | Crown And Bridge, Temporary, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3770 |
| Establishment | Manufacturer |
| 510(k) | K200039 |
| Record published | 2022-02-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 4 to 25 °C; Special storage condition: avoid direct sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 019.3062 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pmma CAD/CAM disc | Polident d.o.o. | 1,123 |
| Trilux | Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. | 929 |
| Vipi Block | Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. | 673 |
| Aidite Pmma | Aidite (Qinhuangdao) Technology Co., Ltd. | 642 |
| Pure Pmma Disc | Quest Dental Material Corporation | 508 |
| Pmma Disk | Yamahachi Dental MFG. Co. | 464 |
| Nic Tone, MDC Dental | MDC Dental | 395 |
| Acry Rock | Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. | 304 |
| Idodentine | Union Dental SA | 255 |
| 10TEMP | Union Dental SA | 220 |
| Temp Premium Flexible | Zirkonzahn SRL | 198 |
| Telio CAD | Ivoclar Vivadent Aktiengesellschaft | 177 |
Showing 12 of 1,508. All products under Crown And Bridge, Temporary, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200039 | 2020-07-31 |
| K102776 | 2011-02-18 |
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.