Anaxdent Pmma
ANAXDENT PMMA DISC U Monolayer BLANK COLOR BL3 98,5/25mm
13manufacturers in China registered for this device type
175catalogue 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.
| 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 | 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 | 2025-02-11 |
| Record revised | 2023-12-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| U Monolayer BLANK BL3 98,5/25mm | In distribution | |
| U MULTI BLANK B2 98,5/12mm | In distribution | |
| Z MULTI BLANK A1 95/20mm | In distribution | |
| U 10-LAYER BLANK B4 98,5/20mm | In distribution | |
| Z Monolayer BLANK A2 95/20mm | In distribution | |
| Z MULTI BLANK B2 98,5/12mm | In distribution | |
| U MULTIBLANK A1 98,5/16mm | In distribution | |
| U MULTI BLANK B0 98,5/12mm | In distribution | |
| Z 10-LAYER BLANK BL1 95/25mm | In distribution | |
| Z 10-LAYER BLANK B1 95/25mm | In distribution | |
| AG MULTI BLANK A1 101/20mm | In distribution | |
| Z MULTI BLANK A2 98,5/12mm | In distribution | |
| U Monolayer BLANK A3 98,5/25mm | In distribution | |
| Z 10-LAYER BLANK A3 95/30mm | In distribution | |
| U Monolayer BLANK BL4 98,5/25mm | In distribution | |
| U MULTI BLANK A2 98,5/25mm | In distribution | |
| U Monolayer BLANK BL4 98,5/16mm | In distribution | |
| U 10-LAYER BLANK BL4 98,5/20mm | In distribution | |
| Z Monolayer BLANK BL1 95/20mm | In distribution | |
| U 10-LAYER BLANK A3,5 98,5/30mm | In distribution | |
| Z 10-LAYER BLANK C1 95/20mm | In distribution | |
| Z 10-LAYER BLANK BL3 95/25mm | In distribution | |
| U 10-LAYER BL1 BLANK 98,5/20mm | In distribution | |
| Z MULTI BLANK B1 95/20mm | In distribution | |
| Z MULTI BLANK A3,5 95/20mm | In distribution | |
| U 10-LAYER BLANK BL1 98,5/30mm | In distribution | |
| U MULTIBLANK A3 98,5/20mm | In distribution | |
| Z 10-LAYER BLANK C3 95/20mm | In distribution | |
| Z 10-LAYER BLANK A2 95/30mm | In distribution | |
| U 10-LAYER BLANK BL3 98,5/25mm | In distribution | |
| Z 10-LAYER BLANK A3 95/25mm | In distribution | |
| Z MULTI BLANK A3,5 95/16mm | In distribution | |
| Z CLEAR BLANK 95/16mm | In distribution | |
| Z Monolayer BLANK B1 95/25mm | In distribution | |
| U 10-LAYER BLANK C2 98,5/20mm | In distribution | |
| U 10-LAYER BLANK BL2 98,5/30mm | In distribution | |
| Z MULTI BLANK A2 95/20mm | In distribution | |
| Z 10-LAYER BLANK B0 95/30mm | In distribution | |
| Z 10-LAYER BLANK C2 95/20mm | In distribution | |
| Z Monolayer BLANK A3 95/25mm | In distribution | |
| Z 10-LAYER A3 BLANK 95/20mm | In distribution | |
| U 10-LAYER BLANK D2 98,5/25mm | In distribution | |
| AG CLEAR BLANK 101/20mm | In distribution | |
| Z 10-LAYER BLANK BL2 95/25mm | In distribution | |
| U Monolayer BLANK BL3 98,5/20mm | In distribution | |
| U MULTIBLANK B0 98,5/20mm | In distribution | |
| U 10-LAYER BLANK BL3 98,5/30mm | In distribution | |
| U 10-LAYER BLANK B2 98,5/20mm | In distribution | |
| U 10-LAYER BLANK A2 98,5/30mm | In distribution | |
| U MULTIBLANK A2 98,5/20mm | In distribution | |
| U 10-LAYER BLANK B3 98,5/25mm | In distribution | |
| U 10-LAYER BLANK B1 98,5/20mm | In distribution | |
| U 10-LAYER BLANK BL4 98,5/30mm | In distribution | |
| Z 10-LAYER A2 BLANK 95/20mm | In distribution | |
| U 10-LAYER BLANK A3,5 98,5/20mm | In distribution | |
| U MULTIBLANK B0 98,5/16mm | In distribution | |
| Z MULTI BLANK B0 95/20mm | In distribution | |
| U MULTIBLANK A2 98,5/16mm | In distribution | |
| U 10-LAYER BLANK BL3 98,5/20mm | In distribution | |
| U 10-LAYER BLANK D3 98,5/25mm | In distribution | |
| U 10-LAYER BLANK A1 98,5/30mm | In distribution | |
| U Monolayer BLANK A1 98,5/25mm | In distribution | |
| U Monolayer BLANK A1 98,5/16mm | In distribution | |
| Z 10-LAYER BLANK A3,5 95/30mm | In distribution | |
| U MULTI BLANK A1 98,5/25mm | In distribution | |
| U MULTIBLANK D2 98,5/20mm | In distribution | |
| Z 10-LAYER BLANK B4 95/20mm | In distribution | |
| U 10-LAYER BLANK A1 98,5/25mm | In distribution | |
| U 10-LAYER BLANK B1 98,5/30mm | In distribution | |
| Z 10-LAYER BLANK B1 95/30mm | In distribution | |
| Z 10-LAYER BLANK BL4 95/25mm | In distribution | |
| U 10-LAYER BLANK C3 98,5/20mm | In distribution | |
| U MULTIBLANK A3,5 98,5/20mm | In distribution | |
| Z 10-LAYER BLANK A1 95/30mm | In distribution | |
| U MULTI BLANK A3 98,5/12mm | In distribution | |
| U 10-LAYER BLANK C1 98,5/25mm | In distribution | |
| U MULTIBLANK A1 98,5/20mm | In distribution | |
| U 10-LAYER BLANK BL2 98,5/25mm | In distribution | |
| Z MULTI BLANK B2 95/20mm | In distribution | |
| Z Monolayer BLANK BL1 95/25mm | In distribution | |
| Z MULTI BLANK A3 95/20mm | In distribution | |
| Z MULTI BLANK B1 98,5/12mm | In distribution | |
| Z 10-LAYER BL3 BLANK 95/20mm | In distribution | |
| Z Monolayer BLANK BL3 95/20mm | In distribution | |
| Z 10-LAYER BLANK A1 95/20mm | In distribution | |
| U 10-LAYER BLANK A1 98,5/20mm | In distribution | |
| U MULTI BLANK A3 98,5/25mm | In distribution | |
| AG MULTI BLANK A3 101/20mm | In distribution | |
| U Monolayer BLANK B1 98,5/20mm | In distribution | |
| U 10-LAYER BLANK BL4 98,5/25mm | In distribution | |
| AG MULTI BLANK B1 101/20mm | In distribution | |
| Z 10-LAYER BLANK B3 95/20mm | In distribution | |
| U MULTIBLANK B1 98,5/16mm | In distribution | |
| Z Monolayer BLANK B1 95/20mm | In distribution | |
| U Monolayer BLANK A2 98,5/16mm | In distribution | |
| U 10-LAYER BLANK A2 98,5/20mm | In distribution | |
| Z MULTI BLANK B1 95/16mm | In distribution | |
| AG MULTI BLANK B0 101/20mm | In distribution | |
| Z 10-LAYER BLANK A4 95/20mm | In distribution | |
| Z CLEAR BLANK 95/20mm | In distribution | |
| Z Monolayer BLANK BL2 95/20mm | In distribution | |
| U MULTIBLANK B1 98,5/20mm | In distribution | |
| U MULTIBLANK D3 98,5/20mm | In distribution | |
| U 10-LAYER BLANK C4 98,5/20mm | In distribution | |
| Z 10-LAYER A3,5 BLANK 95/20mm | In distribution | |
| U Monolayer BLANK A3 98,5/20mm | In distribution | |
| U CLEAR BLANK 98,5/20mm | In distribution | |
| U 10-LAYER BLANK BL1 98,5/20mm | In distribution | |
| U 10-LAYER BLANK B2 98,5/25mm | In distribution | |
| Z Monolayer BLANK A1 95/20mm | In distribution | |
| U Monolayer BLANK B1 98,5/25mm | In distribution | |
| U 10-LAYER BLANK B0 98,5/20mm | In distribution | |
| Z 10-LAYER B1 BLANK 95/20mm | In distribution | |
| U 10-LAYER BLANK A3 98,5/25mm | In distribution | |
| Z 10-LAYER BLANK A1 95/25mm | In distribution | |
| U 10-LAYER BLANK C1 98,5/20mm | In distribution | |
| Z MULTI BLANK A1 95/16mm | In distribution | |
| U Monolayer BLANK BL1 98,5/25mm | In distribution | |
| U RADIOPAQUE BLANK 98,5/20mm | In distribution | |
| Z 10-LAYER B2 BLANK 95/20mm | In distribution | |
| U MULTI BLANK A2 98,5/12mm | In distribution | |
| U MULTIBLANK A3 98,5/16mm | In distribution | |
| AG MULTI BLANK A2 101/20mm | In distribution | |
| U MULTI BLANK A1 98,5/12mm | In distribution | |
| Z Monolayer BLANK BL3 95/25mm | In distribution | |
| Z MULTI BLANK B0 95/16mm | In distribution | |
| Z MULTI BLANK A1 98,5/12mm | In distribution | |
| U Monolayer BLANK BL1 98,5/20mm | In distribution | |
| U Monolayer BLANK A2 98,5/20mm | In distribution | |
| AG MULTI BLANK B2 101/20mm | In distribution | |
| Z 10-LAYER BLANK A3,5 95/25mm | In distribution | |
| Z Monolayer BLANK BL2 95/25mm | In distribution | |
| U Monolayer BLANK A3 98,5/16mm | In distribution | |
| U MULTIBLANK A3,5 98,5/16mm | In distribution | |
| U 10-LAYER BLANK A2 98,5/25mm | In distribution | |
| U MULTIBLANK B2 98,5/16mm | In distribution | |
| U 10-LAYER BLANK D2 98,5/20mm | In distribution | |
| Z MULTI BLANK A3 95/16mm | In distribution | |
| U MULTI BLANK B1 98,5/12mm | In distribution | |
| Z MULTI BLANK A2 95/16mm | In distribution | |
| Z 10-LAYER BLANK BL3 95/30mm | In distribution | |
| Z 10-LAYER B0 BLANK 95/25mm | In distribution | |
| Z 10-LAYER BLANK BL2 95/20mm | In distribution | |
| U 10-LAYER BLANK A3 98,5/30mm | In distribution | |
| Z MULTI BLANK B2 95/16mm | In distribution | |
| U 10-LAYER BLANK B3 98,5/20mm | In distribution | |
| Z MULTI BLANK B0 98,5/12mm | In distribution | |
| U 10-LAYER BLANK A3 98,5/20mm | In distribution | |
| Z Monolayer BLANK A1 95/25mm | In distribution | |
| Z 10-LAYER BL1 BLANK 95/20mm | In distribution | |
| U Monolayer BLANK BL3 98,5/16mm | In distribution | |
| Z MULTI BLANK A3,5 98,5/12mm | In distribution | |
| Z 10-LAYER BLANK A2 95/25mm | In distribution | |
| Z MULTI BLANK A3 98,5/12mm | In distribution | |
| U 10-LAYER BLANK B1 98,5/25mm | In distribution | |
| U 10-LAYER BLANK A4 98,5/20mm | In distribution | |
| U 10-LAYER BLANK A3,5 98,5/25mm | In distribution | |
| U Monolayer BLANK BL1 98,5/16mm | In distribution | |
| Z Monolayer BLANK A3 95/20mm | In distribution | |
| U MULTI BLANK A3,5 98,5/12mm | In distribution | |
| U Monolayer BLANK A1 98,5/20mm | In distribution | |
| U 10-LAYER BLANK BL2 98,5/20mm | In distribution | |
| U 10-LAYER BLANK BL1 98,5/25mm | In distribution | |
| U Monolayer BLANK A2 98,5/25mm | In distribution | |
| Z Monolayer BLANK A2 95/25mm | In distribution | |
| U CLEAR BLANK 98,5/16mm | In distribution | |
| U 10-LAYER BLANK D3 98,5/20mm | In distribution | |
| U MULTIBLANK B2 98,5/20mm | In distribution | |
| U Monolayer BLANK BL4 98,5/20mm | In distribution | |
| Z RADIOPAQUE BLANK 95/20mm | In distribution | |
| U 10-LAYER BLANK C1 98,5/30mm | In distribution | |
| Z 10-LAYER B0 BLANK 95/20mm | In distribution | |
| Z 10-LAYER C4 BLANK 95/20mm | In distribution | |
| U 10-LAYER BLANK BL3 98,5/20mm | Withdrawn | |
| Z 10-LAYER BL2 BLANK 95/20mm | Withdrawn |
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
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.