Juvora™ Dental Disc
The Juvora Dental Disc is a thermoplastic blank for CAD/CAM manufacture of full or partial removable dentures and implant overdentures. The disc provides the material from which the dental…
The Juvora Dental Disc is a thermoplastic blank for CAD/CAM manufacture of full or partial removable dentures and implant overdentures. The disc provides the material from which the dental prosthesis is fabricated according to its digital design.
It is made from PEEK-OPTIMA LT1, an implant-grade polyetheretherketone polymer. The material is supplied as a cylindrical, puck-shaped disc for processing in the dental fabrication workflow.
Listed Item
JUVORA™ Natural Dental Disc – 95mm x 16mm 1 unit
Disc Form
The Juvora product range includes discs with and without a step. This listed Natural Dental Disc configuration measures 95 mm in diameter and 16 mm in thickness.
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| 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 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Juvora, United Kingdom |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| 510(k) | K132725 |
| Record published | 2018-06-14 |
| Record revised | 2023-07-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 95 to 98 mm; height 16 to 30 mm |
| Distribution end date | 2023-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 540050 | Outer Diameter 95 mm | Withdrawn |
| 540013 | Height 16 mm | Withdrawn |
| 540015 | Height 18 mm | Withdrawn |
| 540017 | Height 20 mm | Withdrawn |
| 540111 | Outer Diameter 95 mm | Withdrawn |
| 540023 | Height 30 mm | Withdrawn |
| 540021 | Height 25 mm | Withdrawn |
| 540019 | Height 22 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Nobilium | Cmp Industries, LLC | 167 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Unbreakable by TCS | Thermoplastic Comfort SYS | 96 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181331 | 2018-12-21 |
| K160918 | 2017-02-13 |
| K132725 | 2014-01-23 |
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.