TPH Spectra® Universal Composite Restorative Low Viscosity
TPH Spectra® Universal Composite Restorative, LV, Easy-Twist Syringe Refill, C2-O, 1 (3g)
10manufacturers in China registered for this device type
53catalogue numbers in this listing
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 | 2024-05-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry. |
| Sizes | Weight 0.25 to 3 g |
| Distribution end date | 2024-05-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 642612 | 20 Compules® Tips (Blue) 1 Shade (0.25g each) Shade A3 Compules® Tips Caps Color Turquoise | 20 | Withdrawn |
| 642636 | Weight 3 g | Withdrawn | |
| 642807 | 10 Compules® Tips (Blue) 1 Shade (0.25g each) Shade B3 , Compules® Tips Cap Color Royal | 10 | Withdrawn |
| 642837 | 1 Easy-Twist Syringe Refill (3g) Shade CE Shade Label Color Light Blue | Withdrawn | |
| 642829 | Weight 3 g | Withdrawn | |
| 642801 | 10 Compules® Tips (Blue) 1 Shade (0.25g each) Shade DB , Compules® Tips Cap Color DarkTaupe | 10 | Withdrawn |
| 642631 | 1 Easy-Twist Syringe Refill (3g) Shade A2 Shade Label Color Black | Withdrawn | |
| 642811 | Weight 0.25 g | 10 | Withdrawn |
| 642803 | Weight 0.25 g | 10 | Withdrawn |
| 642802 | Weight 0.25 g | 10 | Withdrawn |
| 642806 | 10 Compules® Tips (Blue) 1 Shade (0.25g each) Shade B2 , Compules® Tips Cap Color Yellow | 10 | Withdrawn |
| 642833 | 1 Easy-Twist Syringe Refill (3g) Shade DY Shade Label Color Maize | Withdrawn | |
| 642616 | Weight 0.25 g | 20 | Withdrawn |
| 642613 | Weight 0.25 g | 20 | Withdrawn |
| 642822 | Weight 3 g | Withdrawn | |
| 642600 | Weight 0.25 g | Withdrawn | |
| 642817 | 10 Compules® Tips (Blue) 1 Shade (0.25g each) Shade CE , Compules® Tips Cap Color Light Blue | 10 | Withdrawn |
| 642804 | Weight 0.25 g | 10 | Withdrawn |
| 642821 | Weight 3 g | Withdrawn | |
| 642610 | 20 Compules® Tips (Blue)-1 Shade (0.25g each) Shade A1, Compules® Tips Cap Color Flame | 20 | Withdrawn |
| 642632 | 1 Easy-Twist Syringe Refill (3g) Shade A3 Shade Label Color Turquoise | Withdrawn | |
| 642815 | Weight 0.25 g | 10 | Withdrawn |
| 642630 | Weight 3 g | Withdrawn | |
| 642800 | Weight 0.25 g | 10 | Withdrawn |
| 642823 | Weight 3 g | Withdrawn | |
| 642818 | Weight 0.25 g | 10 | Withdrawn |
| 642834 | Weight 3 g | Withdrawn | |
| 642814 | Weight 0.25 g | 10 | Withdrawn |
| 642831 | Weight 3 g | Withdrawn | |
| 642836 | 1 Easy-Twist Syringe Refill (3g) Shade C2-O Shade Label Color Peach | Withdrawn | |
| 642614 | 20 Compules® Tips (Blue) 1 Shade (0.25g each) Shade B1, Compules® Tips Cap Color White | 20 | Withdrawn |
| 642820 | 1 Easy-Twist Syringe Refill (3g) Shade LB Shade Label Color Light Taupe | Withdrawn | |
| 642809 | 10 Compules® Tips (Blue) 1 Shade (0.25g each) Shade C4 , Compules® Tips Cap Color Brown | 10 | Withdrawn |
| 642813 | Weight 0.25 g | 10 | Withdrawn |
| 642615 | 20 Compules® Tips (Blue) 1 Shade (0.25g each) Shade C2, Compules® Tips Cap Color Tan | 20 | Withdrawn |
| 642808 | Weight 0.25 g | 10 | Withdrawn |
| 642810 | 10 Compules® Tips (Blue) 1 Shade (0.25g each) Shade D3 , Compules® Tips Cap Color Lime | 10 | Withdrawn |
| 642816 | 10 Compules® Tips (Blue) 1 Shade (0.25g each) Shade C2-O , Compules® Tips Cap Color Peach | 10 | Withdrawn |
| 642812 | Weight 0.25 g | 10 | Withdrawn |
| 642634 | 1 Easy-Twist Syringe Refill (3g) Shade B1 Shade Label Color White | Withdrawn | |
| 642838 | Weight 3 g | Withdrawn | |
| 642828 | Weight 3 g | Withdrawn | |
| 642825 | 1 Easy-Twist Syringe Refill (3g) Shade C3 Shade Label Color Gray | Withdrawn | |
| 642824 | Weight 3 g | Withdrawn | |
| 642633 | Weight 3 g | Withdrawn | |
| 642830 | 1 Easy-Twist Syringe Refill (3g) Shade D3 Shade Label Color Lime | Withdrawn | |
| 642826 | 1 Easy-Twist Syringe Refill (3g) Shade B2 Shade Label Color Yellow | Withdrawn | |
| 642835 | 1 Easy-Twist Syringe Refill (3g) Shade B1-I Shade Label Color Sky | Withdrawn | |
| 642611 | 20 Compules® Tips (Blue) 1 Shade (0.25g each) Shade A2, Compules® Tips Cap Color Black | 20 | Withdrawn |
| 642832 | 1 Easy-Twist Syringe Refill (3g) Shade XL Shade Label Color Process Blue | Withdrawn | |
| 642827 | 1 Easy-Twist Syringe Refill (3g) Shade B3 Shade Label Color Royal | Withdrawn | |
| 642635 | 1 Easy-Twist Syringe Refill (3g) Shade C2 Shade Label Color Tan | Withdrawn | |
| 642805 | 10 Compules® Tips (Blue) 1 Shade (0.25g each) Shade C3 , Compules® Tips Cap Color Gray | 10 | Withdrawn |
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.