Glacier
43 catalogue numbers from GLACIER 5 SYR KT, listed by SDI Ltd., Australia, under Material, Tooth Shade, Resin. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
43catalogue numbers in this listing
3510(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 | SDI Ltd., Australia |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Manufacturer |
| 510(k) | K941899 |
| Record published | 2016-09-28 |
| Record revised | 2018-07-06 (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, manufacturing date |
| Storage | Handling environment atmospheric pressure 10 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GLACIER 5 SYR KT | 5 | In distribution | |
| GLACIER 1 SYR B2 | In distribution | ||
| GLACIER 1 SYR B | In distribution | ||
| GLACIER 1 SYR C3 | In distribution | ||
| GLACIER COMP INTRO KT | 50 | In distribution | |
| GLACIER 20 COMP OC2 | 20 | In distribution | |
| GLACIER 20 COMP C3 | 20 | In distribution | |
| GLACIER 20 COMP I | 20 | In distribution | |
| GLACIER 1 SYR C2 | In distribution | ||
| GLACIER 20 COMP C4 | 20 | In distribution | |
| GLACIER 1 SYR OB4 | In distribution | ||
| GLACIER 1 SYR A3.5 | In distribution | ||
| GLACIER 20 COMP A3.5 | 20 | In distribution | |
| GLACIER 1 SYR B3 | In distribution | ||
| GLACIER 20 COMP B2 | 20 | In distribution | |
| GLACIER 20 COMP A2 | 20 | In distribution | |
| GLACIER 1 SYR I | In distribution | ||
| GLACIER 1 SYR OC2 | In distribution | ||
| GLACIER 1 SYR OD3 | In distribution | ||
| GLACIER 1 SYR B4 | In distribution | ||
| GLACIER 1 SYR C4 | In distribution | ||
| GLACIER 20 COMP A4 | 20 | In distribution | |
| GLACIER 20 COMP OA2 | 20 | In distribution | |
| GLACIER 20 COMP A3 | 20 | In distribution | |
| GLACIER 1 SYR A1 | In distribution | ||
| GLACIER 1 SYR OA3 | In distribution | ||
| GLACIER 1 SYR OA2 | In distribution | ||
| GLACIER 20 COMP B | 20 | In distribution | |
| GLACIER 20 COMP A1 | 20 | In distribution | |
| GLACIER 20 COMP B1 | 20 | In distribution | |
| GLACIER 20 COMP C2 | 20 | In distribution | |
| GLACIER 20 COMP B4 | 20 | In distribution | |
| GLACIER 1 SYR A4 | In distribution | ||
| GLACIER 1 SYR OC4 | In distribution | ||
| GLACIER 1 SYR A3 | In distribution | ||
| GLACIER 1 SYR OB3 | In distribution | ||
| GLACIER 1 SYR A2 | In distribution | ||
| GLACIER 1 SYR OA3.5 | In distribution | ||
| GLACIER 20 COMP OA3.5 | 20 | In distribution | |
| GLACIER 1 SYR D3 | In distribution | ||
| GLACIER 20 COMP D3 | 20 | In distribution | |
| GLACIER 20 COMP B3 | 20 | In distribution | |
| GLACIER 1 SYR B1 | 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 |
|---|---|
| K222581 | 2022-10-28 |
| K222583 | 2022-10-28 |
| K102984 | 2010-12-08 |
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.