Prisma® Gloss™
Metal Mandrel for Prisma® Gloss™ Polishing Cups, 3 Metal Mandrels
10manufacturers in China registered for this device type
1catalogue number
32510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry.; Storage environment temperature 10 to 24 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 624025 | 3 Metal Mandrels | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K083841 | 2009-04-14 |
| K083326 | 2009-02-10 |
| K052097 | 2005-08-12 |
| K050880 | 2005-04-22 |
| K040144 | 2004-04-01 |
| K984387 | 1999-01-13 |
| K982318 | 1998-09-15 |
| K982395 | 1998-08-18 |
| K973221 | 1998-02-09 |
| K973235 | 1998-02-05 |
| K950991 | 1995-03-23 |
| K945769 | 1994-12-29 |
| K942031 | 1994-06-10 |
| K932395 | 1993-08-25 |
| K923236 | 1992-09-11 |
| K905476 | 1991-02-20 |
| K896564 | 1990-02-09 |
| K872907 | 1987-08-03 |
| K863552 | 1986-10-17 |
| K863174 | 1986-10-07 |
| K863092 | 1986-09-19 |
| K853431 | 1985-10-31 |
| K852659 | 1985-07-30 |
| K852658 | 1985-07-24 |
| K852151 | 1985-07-01 |
| K850911 | 1985-04-16 |
| K830442 | 1983-03-17 |
| K813357 | 1982-01-07 |
| K802975 | 1981-01-14 |
| K802125 | 1980-09-16 |
| K801732 | 1980-08-07 |
| K801092 | 1980-05-20 |
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.