PEEK BioSolution
PEEK BioSolution white diameter 98,5mm, thickness 10mm
10manufacturers in China registered for this device type
42catalogue numbers in this listing
1510(k) clearance
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 | Merz Dental Gmbh, Germany |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Manufacturer |
| Record published | 2018-02-20 |
| Record revised | 2025-01-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 95 to 100 mm; height 10 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PEEK BioSolution white diameter 95mm, thickness 26mm | Outer Diameter 95 mm | In distribution |
| PEEK BioSolution white diameter 98,5mm, thickness 10mm | Outer Diameter 98.5 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 100mm, thickness 10mm | Height 10 mm | In distribution |
| PEEK BioSolution white diameter 98,5mm, thickness 26mm | Outer Diameter 98.5 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 95mm, thickness 12mm | Outer Diameter 95 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 98,5mm, thickness 26mm | Outer Diameter 98.5 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 95mm, thickness 20mm | Outer Diameter 95 mm | In distribution |
| PEEK BioSolution white diameter 98,5mm, thickness 30mm | Height 30 mm | In distribution |
| PEEK BioSolution white diameter 98,5mm, thickness 16mm | Outer Diameter 98.5 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 95mm, thickness 30mm | Height 30 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 95mm, thickness 26mm | Outer Diameter 95 mm | In distribution |
| PEEK BioSolution white diameter 100mm, thickness 10mm | Outer Diameter 100 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 95mm, thickness 16mm | Height 16 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 100mm, thickness 30mm | Height 30 mm | In distribution |
| PEEK BioSolution white diameter 100mm, thickness 26mm | Outer Diameter 100 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 100mm, thickness 16mm | Height 16 mm | In distribution |
| PEEK BioSolution white diameter 95mm, thickness 20mm | Height 20 mm | In distribution |
| PEEK BioSolution white diameter 95mm, thickness 12mm | Height 12 mm | In distribution |
| PEEK BioSolution white diameter 95mm, thickness 30mm | Height 30 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 98,5mm, thickness 12mm | Outer Diameter 98.5 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 100mm, thickness 26mm | Outer Diameter 100 mm | In distribution |
| PEEK BioSolution white diameter 98,5mm, thickness 24mm | Outer Diameter 98.5 mm | In distribution |
| PEEK BioSolution white diameter 100mm, thickness 30mm | Height 30 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 98,5mm, thickness 16mm | Height 16 mm | In distribution |
| PEEK BioSolution white diameter 95mm, thickness 16mm | Outer Diameter 95 mm | In distribution |
| PEEK BioSolution white diameter 100mm, thickness 20mm | Height 20 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 98,5mm, thickness 24mm | Height 24 mm | In distribution |
| PEEK BioSolution white diameter 100mm, thickness 16mm | Outer Diameter 100 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 100mm, thickness 12mm | Outer Diameter 100 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 100mm, thickness 20mm | Outer Diameter 100 mm | In distribution |
| PEEK BioSolution white diameter 98,5mm, thickness 12mm | Height 12 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 98,5mm, thickness 10mm | Height 10 mm | In distribution |
| PEEK BioSolution white diameter 100mm, thickness 24mm | Outer Diameter 100 mm | In distribution |
| PEEK BioSolution white diameter 98,5mm, thickness 20mm | Height 20 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 95mm, thickness 10mm | Height 10 mm | In distribution |
| PEEK BioSolution white diameter 95mm, thickness 10mm | Outer Diameter 95 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 95mm, thickness 24mm | Height 24 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 98,5mm, thickness 30mm | Height 30 mm | In distribution |
| PEEK BioSolution white diameter 100mm, thickness 12mm | Height 12 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 98,5mm, thickness 20mm | Outer Diameter 98.5 mm | In distribution |
| PEEK BioSolution A2/B2 diameter 100mm, thickness 24mm | Height 24 mm | In distribution |
| PEEK BioSolution white diameter 95mm, thickness 24mm | Outer Diameter 95 mm | 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 |
|---|---|
| K173124 | 2017-12-18 |
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.