Bosworth Trim II
PEMA Temp C&B Standard Kit, 6-1.5 oz Pwd, 4 oz liquid
13manufacturers in China registered for this device type
20catalogue numbers in this listing
2510(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 | Harry J. Bosworth Co., United States |
|---|---|
| FDA product code | EBG |
| Device type | Crown And Bridge, Temporary, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3770 |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2021-10-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight; Special storage condition: Keep away from moisture |
| Sizes | Weight 42 to 454 g; weight 1 to 5 lb; weight 2.27 kg; total volume 118 ml; total volume 4 Fluid Ounce |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0921097 | Weight 42 g | In distribution |
| 092110061 | Weight 1 lb | In distribution |
| 0921094 | Weight 42 g | In distribution |
| 092110069 | Weight 1 lb | In distribution |
| 0921092 | Weight 42 g | In distribution |
| 0921093 | Weight 42 g | In distribution |
| 092110362 | Weight 5 lb | In distribution |
| 092110560 | Weight 42 g | In distribution |
| 0921090 | In distribution | |
| 092110566 | Weight 42 g | In distribution |
| 0921096 | Weight 42 g | In distribution |
| 092110062 | Weight 454 g | In distribution |
| 092110065 | Weight 1 lb | In distribution |
| 092110077 | Weight 1 lb | In distribution |
| 0921095 | Weight 42 g | In distribution |
| 092110366 | Weight 2.27 kg | In distribution |
| 0921091 | Total Volume 118 ml | In distribution |
| 0921106 | Weight 42 g | In distribution |
| 092110369 | Weight 2.27 kg | In distribution |
| 092110059 | Weight 454 g | 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 |
|---|---|
| K961199 | 1996-06-25 |
| K961198 | 1996-05-24 |
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.