CORiTEC Pmma Disc
CORiTEC PMMA Disc, shade B1 translucent thickness 20mm, diameter 98,5mm, with notch
13manufacturers in China registered for this device type
32catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Merz Dental 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) | K071548 |
| Record published | 2017-09-30 |
| Record revised | 2025-01-27 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 98.5 mm; height 20 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CORiTEC PMMA Disc, shade B1 translucent thickness 20mm, diameter 98,5mm, with no | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc, shade B2 translucent thickness 20mm, diameter 98,5mm, with no | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade BL3, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade B2, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc, shade C2 translucent thickness 20mm, diameter 98,5mm, with no | Height 20 mm | In distribution |
| CORiTEC PMMA Disc, shade A4 translucent thickness 20mm, diameter 98,5mm, with no | Height 20 mm | In distribution |
| CORiTEC PMMA Disc, shade D2 translucent thickness 20mm, diameter 98,5mm, with no | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade C4, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade B4, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade A3, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade C3, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade B3, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade D4, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc, shade C1 translucent thickness 20mm, diameter 98,5mm, with no | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade BL4, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade BL2, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc, shade B4 translucent thickness 20mm, diameter 98,5mm, with no | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade A3,5, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade BL1, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade A4, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade D3, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc, shade D4 translucent thickness 20mm, diameter 98,5mm, with no | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc, shade C3 translucent thickness 20mm, diameter 98,5mm, with no | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade C2, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc, shade B3 translucent thickness 20mm, diameter 98,5mm, with no | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade B1, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc, shade C4 translucent thickness 20mm, diameter 98,5mm, with no | Height 20 mm | In distribution |
| CORiTEC PMMA Disc, shade D3 translucent thickness 20mm, diameter 98,5mm, with no | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade C1, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade A1, with notch | Height 20 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade A2, with notch | Outer Diameter 98.5 mm | In distribution |
| CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade D2, with notch | Outer Diameter 98.5 mm | 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 |
|---|---|
| K080556 | 2008-05-02 |
| K071548 | 2007-08-21 |
| K061809 | 2006-09-13 |
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.