EdgeTemp™ Plus Hydraulic Temporary Restorative Material

EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation. It is supplied in a 40g jar in white (tooth-like) color and is…

Registry build 21.09.26

EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation. It is supplied in a 40g jar in white (tooth-like) color and is individually boxed. EdgeTemp™ Plus is a water-based temporary filling material used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity.

13manufacturers in China registered for this device type
1catalogue number

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.

Chinese manufacturers registered for FDA product code EBG
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

Regulatory record for EdgeTemp™ Plus Hydraulic Temporary Restorative Material
Listed by Edge Endo LLC
FDA product code EBG
Device type Crown And Bridge, Temporary, Resin
Device class Class 2
Regulation 21 CFR 872.3770
Record published 2020-08-28
Record revised 2021-10-29 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 1 to 30 °C; Special storage condition: Keep away from sunlight.
Sizes Weight 40 g

Catalogue Numbers

Catalogue numbers for EdgeTemp™ Plus Hydraulic Temporary Restorative Material
Catalogue number Size Status
ETEMPPLUS Weight 40 g In distribution

Same Product Code

Other products under the same FDA 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer