Tempsmart™
TEMPSMART™ 48mL Mixing Tip II SSS (20)
13manufacturers in China registered for this device type
22catalogue numbers in this listing
6510(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 | GC America Inc., United States |
|---|---|
| FDA product code | EBG |
| Device type | Crown And Bridge, Temporary, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3770 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K141562 |
| Record published | 2022-08-19 |
| Record revised | 2026-01-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 25 °C; Storage environment temperature 39 to 77 °F |
| Packaging | Carton of 10 |
| Sizes | Total volume 10 to 48 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 009395 | Total Volume 48 ml | In distribution | |
| 009397 | Total Volume 48 ml | In distribution | |
| 420000 | 20 | In distribution | |
| 009393 | Total Volume 48 ml | In distribution | |
| 009400 | Total Volume 10 ml | In distribution | |
| 009396 | Total Volume 48 ml | In distribution | |
| 009395 | Total Volume 48 ml | In distribution | |
| 009401 | Total Volume 10 ml | In distribution | |
| 009398 | Total Volume 10 ml | In distribution | |
| 009399 | Total Volume 10 ml | In distribution | |
| 009394 | Total Volume 48 ml | In distribution | |
| 009392 | Total Volume 48 ml | In distribution | |
| 009398 | Total Volume 10 ml | In distribution | |
| 009392 | Total Volume 48 ml | In distribution | |
| 009401 | Total Volume 10 ml | In distribution | |
| 009393 | Total Volume 48 ml | In distribution | |
| 009400 | Total Volume 10 ml | In distribution | |
| 009397 | Total Volume 48 ml | In distribution | |
| 009394 | Total Volume 48 ml | In distribution | |
| 420000 | 20 | In distribution | |
| 009399 | Total Volume 10 ml | In distribution | |
| 009396 | Total Volume 48 ml | 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 |
|---|---|
| K193113 | 2020-07-09 |
| K141562 | 2014-09-05 |
| K073106 | 2008-04-11 |
| K003817 | 2001-01-16 |
| K942670 | 1994-10-18 |
| K935960 | 1994-03-04 |
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.