DentaIBT
Catalogue number 03746, listed by Asiga, Australia, under Indirect Bonding Tray. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Yinchili Medical Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 3 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Wuxi EA Medical Instruments Technologies Limited | Wuxi | Jiangsu | Repacker / relabeller | 6 |
| Shenzhen Yongchanghe Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Xiamen Antinsky Industry Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
| Shanghai Smartee Denti-Technology Co., Ltd. | Shanghai | Shanghai | Exporter | 5 |
Record
| Listed by | Asiga, Australia |
|---|---|
| FDA product code | QJJ |
| Device type | Indirect Bonding Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03746 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LuxaPrint Ortho Flex 385 | DMG Digital Enterprises SE | 8 |
| MED610 | Stratasys Ltd | 5 |
| LuxaPrint Ortho Flex NX | DMG Digital Enterprises SE | 5 |
| KeyPrint | Keystone Industries | 2 |
| IDB 2 | Sprintray Inc. | 1 |
| ClearCorrect System Engager Template | Clearcorrect Operating, LLC | 1 |
| ClearCorrect System | Clearcorrect Operating, LLC | 1 |
| Custom Orthodontic Solution | Klowen Braces | 1 |
| Attachment Template | Align Technology, Inc. | 1 |
| Indirect Bond-EZ_HardSoft | Five Star Orthodontic Laboratory & Supply, Inc. | 1 |
| IDB 3 | Sprintray Inc. | 1 |
| Indirect Bond | Five Star Orthodontic Laboratory & Supply, Inc. | 1 |
Showing 12 of 18. All products under Indirect Bonding Tray
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.