Ceramill Temp
Ceramill TEMP middle 71 L20mm US
13manufacturers in China registered for this device type
16catalogue 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 | 2016-09-24 |
| 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 | Height 13 to 20 mm; outer diameter 70 to 98 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ceramill TEMP dark 71 L 20mm US | Height 20 mm | In distribution |
| Ceramill TEMP light 98×20 N/US | Height 20 mm | In distribution |
| Ceramill TEMP light 71XS13mm US | Height 13 mm | In distribution |
| Ceramill TEMP middle 71 L20mm US | Height 20 mm | In distribution |
| Ceramill TEMP dark 71 XS 13mm US | Height 13 mm | In distribution |
| Ceramill TEMP light 71 L 20mm US | Height 20 mm | In distribution |
| Ceramill TEMP middle 98×20 N/US | Height 20 mm | In distribution |
| Ceramill TEMP bleach 71XS13mm US | Height 13 mm | In distribution |
| Ceramill TEMP dark 98×14 N/US | Height 14 mm | In distribution |
| Ceramill TEMP middle 98×14 N/US | Height 14 mm | In distribution |
| Ceramill TEMP bleach 98×20 N/US | Height 20 mm | In distribution |
| Ceramill TEMP bleach 71 L20mm US | Height 20 mm | In distribution |
| Ceramill TEMP middle 71XS13mm US | Height 13 mm | In distribution |
| Ceramill TEMP bleach 98×14 N/US | Height 14 mm | In distribution |
| Ceramill TEMP light 98×14 N/US | Height 14 mm | In distribution |
| Ceramill TEMP dark 98×20 N/US | Height 20 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.