Idodentine
IDODENTINE DISC WHITE RADIOPAQUE 98,5/20mm
14manufacturers in China registered for this device type
25catalogue numbers in this listing
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 | Union Dental SA |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| 510(k) | K150432 |
| Record published | 2016-12-16 |
| Record revised | 2021-10-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DISC PINK VEINED 95/25mm | In distribution | |
| DISC PINK V 98.5/20mm | In distribution | |
| DISC RADIOPAQUE 98,5/20mm | In distribution | |
| DISC A3.5 95/25mm | In distribution | |
| DISC CLEAR 98,5/16mm | In distribution | |
| DISC CLEAR 98,5/20mm | In distribution | |
| DISC CLEAR 95/20mm | In distribution | |
| DISC PINK 95/25mm | In distribution | |
| DISC RADIOPAQUE 95/16mm | In distribution | |
| DISC PINK V 95/30mm | In distribution | |
| DISC PINK VEINED 98,5/25mm | In distribution | |
| DISC A2 95/25mm | In distribution | |
| DISC PINK VEINED 95/16mm | In distribution | |
| DISC MULTI PINK-A3 98,5/25mm | In distribution | |
| DISC PINK 98,5/25mm | In distribution | |
| DISC A2 95/16mm | In distribution | |
| DISC RADIOPAQUE 98,5/16mm | In distribution | |
| DISC CLEAR 101/20mm | In distribution | |
| DISC PINK V 101/20mm | In distribution | |
| DISC MULTI PINK-A1 98,5/25mm | In distribution | |
| DISC PINK 98.5/30mm | In distribution | |
| DISC BG3 95/12mm | In distribution | |
| DISC BG3 95/16mm | In distribution | |
| DISC CLEAR 95/25mm | In distribution | |
| DISC MULTI PINK-B1 98,5/25mm | In distribution |
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
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.