Idodentine

IDODENTINE BLOCK MULTILAYER (3 UNITS) COLOR A1 MEASURES :15,5x19x39mm

Registry build 21.09.26
13manufacturers in China registered for this device type
255catalogue numbers in this listing

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 Idodentine
Listed by Union Dental SA
FDA product code EBG
Device type Crown And Bridge, Temporary, Resin
Device class Class 2
Regulation 21 CFR 872.3770
510(k) K150432
Record published 2019-02-18
Record revised 2023-12-28 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2023-12-27
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Idodentine
Catalogue number Size Status
DISC CLEAR 95/16mm In distribution
DISC BG3 101/20mm In distribution
DISC A3.5 MULTI 95/25mm In distribution
DISC B4 MULTI 98,5/25mm In distribution
DISC A4 10 LAYERS 95/20mm In distribution
DISC B2 MULTI 95/20mm In distribution
DISC B2 MULTI 98,5/16mm In distribution
DISC A1 95/25mm In distribution
DISC B4 3L 98,5/16mm In distribution
DISC A2 101/20mm In distribution
DISC B1 98,5/16mm In distribution
DISC C1 10 LAYERS 98,5/25mm In distribution
DISC DARK PINK V7 (#52) 98,5/30mm In distribution
DISC A1 10 LAYERS 98,5/20mm In distribution
DISC B3 MULTI 101/20mm In distribution
DISC A1 MULTI 95/20mm In distribution
DISC BLUE TRANSP 98,5/16mm In distribution
DISC A3.5 MULTI 98,5/25mm In distribution
DISC RED TRANSP 98,5/20mm In distribution
DISC C1 MULTI 95/20mm In distribution
DISC A4 10 LAYERS 98,5/25mm In distribution
DISC BG3 98,5/16mm In distribution
DISC PINK 95/16mm In distribution
DISC RADIOPAQUE 95/20mm In distribution
DISC B4 MULTI 95/16mm In distribution
DISC B3 MULTI 95/16mm In distribution
BLOCK (3 UNITS) VIOLET 15,5x19x39mm In distribution
DISC B1 98,5/20mm In distribution
DISC A3.5 10 LAYERS 98,5/20mm In distribution
DISC C3 MULTI 98,5/20mm In distribution
DISC C1 MULTI 98,5/16mm In distribution
DISC BL1 MULTI 98,5/25mm In distribution
DISC A2 10 LAYERS 98,5/20mm In distribution
DISC A1 3L 98,5/16mm In distribution
DISC C2 10 LAYERS 98,5/25mm In distribution
DISC PINK V 95/20mm In distribution
DISC D2 MULTI 98,5/16mm In distribution
DISC DARK PINK V2 (#1L) 98,5/25mm In distribution
DISC B2 10 LAYERS 98,5/20mm In distribution
DISC A1 98,5/25mm In distribution
DISC B3 10 LAYERS 95/25mm In distribution
DISC BL4 10 LAYERS 98,5/20mm In distribution
DISC C2 MULTI 98,5/20mm In distribution
DISC B3 3L 98,5/16mm In distribution
DISC A3 98,5/16mm In distribution
DISC D2 98,5/25mm In distribution
DISC C4 MULTI 98,5/20mm In distribution
DISC B1 95/16mm In distribution
DISC C1 10 LAYERS 95/25mm In distribution
DISC C2 98,5/25mm In distribution
DISC B1 MULTI 95/20mm In distribution
DISC BG3 95/25mm In distribution
DISC BL1 10 LAYERS 98,5/20mm In distribution
DISC A1 95/16mm In distribution
DISC B1 95/25mm In distribution
DISC A3.5 3L 98,5/16mm In distribution
DISC A3 MULTI 95/25mm In distribution
DISC PINK V 98.5/30mm In distribution
DISC PINK 95/30mm In distribution
DISC DARK PINK V7 (#52) 98,5/25mm In distribution
DISC GREEN TRANSP 98,5/20mm In distribution
DISC MULTI PINK-A2 98,5/25mm In distribution
DISC PINK TRANSP 98,5/20mm In distribution
DISC C3 MULTI 98,5/16mm In distribution
DISC B3 MULTI 98,5/20mm In distribution
DISC A1 3L 95/16mm In distribution
BLOCK (3 UNITS) A3 – 15,5x19x39mm In distribution
DISC VIOLET TRANSP 98,5/16mm In distribution
DISC A2 MULTI 95/20mm In distribution
DISC C1 MULTI 95/25mm In distribution
DISC B1 10 LAYERS 95/20mm In distribution
DISC A1 MULTI 98,5/25mm In distribution
DISC A2 3L 98,5/16mm In distribution
DISC B1 98,5/25mm In distribution
DISC B0- BL2 MULTI 98,5/25mm In distribution
DISC A3 MULTI 98,5/20mm In distribution
DISC MULTI PINK-B2 98,5/25mm In distribution
DISC B1 10 LAYERS 98,5/20mm In distribution
DISC D2 10 LAYERS 98,5/20mm In distribution
DISC C4 MULTI 98,5/16mm In distribution
DISC B3 MULTI 95/25mm In distribution
DISC A3.5 98,5/25mm In distribution
DISC DARK PINK V6 (#51) 98,5/30mm In distribution
DISC B2 3L 98,5/16mm In distribution
DISC CLEAR 98,5/25mm In distribution
DISC D3 MULTI 95/20mm In distribution
DISC D4 MULTI 95/16mm In distribution
DISC D3 MULTI 95/16mm In distribution
DISC DARK PINK V5 (#49) 98,5/30mm In distribution
DISC GREEN TRANSP 98,5/16mm In distribution
DISC B1 10 LAYERS 95/25mm In distribution
DISC C3 10 LAYERS 98,5/20mm In distribution
DISC A3.5 MULTI 95/16mm In distribution
DISC B2 MULTI 98,5/25mm In distribution
DISC B0 MULTI 95/20mm In distribution
DISC C2 10 LAYERS 95/25mm In distribution
DISC DARK PINK V5 (#49) 98,5/25mm In distribution
DISC B0 MULTI 101/20mm In distribution
DISC D2 MULTI 95/20mm In distribution
DISC A2 10 LAYERS 95/20mm In distribution
DISC B4 MULTI 98,5/16mm In distribution
DISC C1 MULTI 95/16mm In distribution
DISC A2 98,5/20mm In distribution
DISC B0 MULTI 98,5/20mm In distribution
DISC C2 3L 95/16mm In distribution
DISC A1 95/20mm In distribution
DISC A1 98,5/20mm In distribution
DISC A4 MULTI 98,5/16mm In distribution
DISC A3 10 LAYERS 98,5/20mm In distribution
DISC B1 MULTI 98,5/20mm In distribution
DISC C4 98,5/25mm In distribution
DISC B4 MULTI 98,5/20mm In distribution
DISC A3 MULTI 98,5/25mm In distribution
DISC A1 10 LAYERS 98,5/25mm In distribution
DISC DARK PINK V3 (#200) 98,5/25mm In distribution
DISC B0 MULTI 98,5/16mm In distribution
DISC A2 3L 95/16mm In distribution
BLOCK (3 UNITS) MULTI A1 – 15,5x19x39mm In distribution
DISC B1 MULTI 98,5/25mm In distribution
DISC MULTI PINK-B0 98,5/25mm In distribution
DISC B0- BL2 10 LAYERS 98,5/20mm In distribution
DISC A3 3L 95/16mm In distribution
DISC B1 10 LAYERS 98,5/25mm In distribution
DISC B0- BL2 10 LAYERS 98,5/25mm In distribution
DISC B1 95/20mm In distribution
DISC C1 MULTI 98,5/20mm In distribution
DISC B2 10 LAYERS 98,5/25mm In distribution
DISC A4 MULTI 95/25mm In distribution
DISC B2 10 LAYERS 95/20mm In distribution
DISC BLUE TRANSP 98,5/20mm In distribution
DISC C3 98,5/25mm In distribution
DISC C1 10 LAYERS 98,5/20mm In distribution
DISC A2 10 LAYERS 95/25mm In distribution
DISC C2 MULTI 95/20mm In distribution
DISC C2 10 LAYERS 95/20mm In distribution
DISC A3 95/25mm In distribution
DISC C2 MULTI 101/20mm In distribution
DISC A3 10 LAYERS 95/25mm In distribution
DISC A1 MULTI 98,5/16mm In distribution
DISC A3 95/16mm In distribution
DISC B2 98,5/25mm In distribution
DISC VIOLET TRANSP 98,5/20mm In distribution
DISC A2 95/20mm In distribution
DISC A2 MULTI 95/16mm In distribution
DISC C2 MULTI 98,5/25mm In distribution
DISC A1 MULTI 101/20mm In distribution
DISC A MULTI 95/16mm In distribution
DISC RADIOPAQUE 98,5/25mm In distribution
DISC B4 MULTI 95/25mm In distribution
DISC B1 MULTI 95/25mm In distribution
DISC A3.5 MULTI 98,5/20mm In distribution
DISC A3.5 10 LAYERS 95/20mm In distribution
DISC A3 MULTI 95/20mm In distribution
DISC A4 10 LAYERS 98,5/20mm In distribution
DISC A1 MULTI 98,5/20mm In distribution
DISC B2 MULTI 95/25mm In distribution
DISC A1 MULTI 101/20mm In distribution
DISC A1 MULTI 95/16mm In distribution
DISC B0- BL2 10 LAYERS 95/20mm In distribution
DISC B4 10 LAYERS 95/25mm In distribution
DISC C1 98,5/25mm In distribution
DISC B4 10 LAYERS 95/20mm In distribution
DISC BL2 10 LAYERS 98,5/20mm In distribution
DISC B1 MULTI 98,5/16mm In distribution
DISC D3 MULTI 98,5/16mm In distribution
DISC C2 MULTI 95/16mm In distribution
DISC A3 MULTI 101/20mm In distribution
BLOCK (3 UNITS) A2 – 15,5x19x39mm In distribution
DISC A2 MULTI 98,5/16mm In distribution
DISC PINK 95/20mm In distribution
DISC A3 98,5/20mm In distribution
DISC A3 MULTI 95/16mm In distribution
DISC DARK PINK V2 (#1L) 98,5/30mm In distribution
DISC B0- BL2 MULTI 95/25mm In distribution
BLOCK (3 UNITS) A1 – 15,5x19x39mm In distribution
DISC RED TRANSP 98,5/16mm In distribution
DISC C2 MULTI 98,5/16mm In distribution
DISC B3 10 LAYERS 98,5/20mm In distribution
DISC BL2 MULTI 98,5/20mm In distribution
DISC C2 10 LAYERS 98,5/20mm In distribution
DISC B1 3L 98,5/16mm In distribution
DISC C3 MULTI 95/16mm In distribution
DISC A2 98,5/25mm In distribution
DISC D2 MULTI 95/16mm In distribution
DISC A2 10 LAYERS 98,5/25mm In distribution
DISC A3 MULTI 98,5/16mm In distribution
DISC BG3 98,5/25mm In distribution
DISC A1 MULTI 95/25mm In distribution
DISC D3 98,5/25mm In distribution
DISC C1 MULTI 98,5/25mm In distribution
DISC C1 3L 98,5/16mm In distribution
DISC B4 98,5/25mm In distribution
DISC A3 101/20mm In distribution
DISC A3 95/20mm In distribution
DISC C4 MULTI 95/20mm In distribution
DISC A4 MULTI 98,5/20mm In distribution
DISC C1 10 LAYERS 95/20mm In distribution
DISC D4 MULTI 95/20mm In distribution
DISC B3 10 LAYERS 98,5/25mm In distribution
DISC B0 – BL2 MULTI 95/16mm In distribution
DISC A4 3L 98,5/16mm In distribution
DISC PINK TRANSP 98,5/16mm In distribution
DISC A3 10 LAYERS 98,5/25mm In distribution
DISC A4 98,5/25mm In distribution
DISC B1 MULTI 95/16mm In distribution
DISC C3 MULTI 95/20mm In distribution
DISC B3 10 LAYERS 95/20mm In distribution
DISC BL3 10 LAYERS 98,5/20mm In distribution
DISC A4 MULTI 98,5/25mm In distribution
DISC C2 3L 98,5/16mm In distribution
DISC DARK PINK V1 (#1) 98,5/25mm In distribution
DISC B1 101/20mm In distribution
DISC A1 101/20mm In distribution
DISC A2 MULTI 98,5/25mm In distribution
DISC D4 98,5/25mm In distribution
DISC B2 MULTI 98,5/20mm In distribution
BLOCK (3 UNITS) MULTI A2 – 15,5x19x39mm In distribution
DISC A2 MULTI 98.5/20mm In distribution
DISC D4 MULTI 98,5/16mm In distribution
DISC B3 MULTI 98,5/16mm In distribution
DISC A4 10 LAYERS 95/25mm In distribution
DISC B0 3L 98,5/16mm In distribution
DISC A3 10 LAYERS 95/20mm In distribution
DISC B0- BL2 10 LAYERS 95/25mm In distribution
DISC DARK PINK V6 (#51) 98,5/25mm In distribution
DISC B4 10 LAYERS 98,5/20mm In distribution
DISC BG3 95/20mm In distribution
BLOCK (3 UNITS) MULTI A3 – 15,5x19x39mm In distribution
DISC A1 10 LAYERS 95/25mm In distribution
DISC A3 98,5/25mm In distribution
DISC A2 MULTI 95/25mm In distribution
DISC RADIOPAQUE 95/25mm In distribution
DISC B4 MULTI 95/20mm In distribution
DISC B4 10 LAYERS 98,5/25mm In distribution
DISC B2 MULTI 95/16mm In distribution
DISC B3 MULTI 95/20mm In distribution
DISC A1 10 LAYERS 95/20mm In distribution
DISC A1 98,5/16mm In distribution
DISC B3 3L 95/16mm In distribution
DISC B2 10 LAYERS 95/25mm In distribution
DISC A3.5 10 LAYERS 98,5/25mm In distribution
DISC B0 3L 95/16mm In distribution
DISC C4 MULTI 95/16mm In distribution
DISC DARK PINK V3 (#200) 98,5/30mm In distribution
DISC A3 3L 98,5/16mm In distribution
DISC BG3 98,5/20mm In distribution
DISC B3 98,5/25mm In distribution
DISC A3.5 10 LAYERS 95/25mm In distribution
DISC DARK PINK V1 (#1) 98,5/30mm In distribution
DISC A2 98,5/16mm In distribution

Showing 250 of 255 catalogue numbers.

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
10TEMP Union Dental SA 220
Temp Premium Flexible Zirkonzahn SRL 198
Telio CAD Ivoclar Vivadent Aktiengesellschaft 177
Anaxdent Pmma Union Dental SA 175

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