KeyPrint
KeyOrtho IBT 0.5KG
6manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Keystone Industries, United States |
|---|---|
| FDA product code | QJJ |
| Device type | Indirect Bonding Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from moisture; Special storage condition: Keep out of direct sunlight; Storage environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Sizes | Weight 0.5 to 1 kg; total volume 17.6 to 35.3 Fluid Ounce |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4220008 | Weight 1 kg | In distribution |
| 4200008 | Total Volume 17.6 Fluid Ounce | 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 |
| IDB 2 | Sprintray Inc. | 1 |
| ClearCorrect System Engager Template | Clearcorrect Operating, LLC | 1 |
| DentaIBT | Asiga | 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.