ClearCorrect System Engager Template
Accessory device of the ClearCorrect System clear aligner system. Device is used by the clinician to add composite features to the teeth, referred to as Engagers. The Engagers have…
Accessory device of the ClearCorrect System clear aligner system. Device is used by the clinician to add composite features to the teeth, referred to as Engagers. The Engagers have orthodontic force applied to them by the Aligners of the ClearCorrect System. The use of Engagers facilitates Aligner retention on the teeth and also facilities certain tooth movements that are difficult to achieve by applying force to the tooth surface itself. The Engager Template is used by the clinician in the clinical setting. The device is single use and disposed of after use. Duration of use is less than one hour.
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 | Clearcorrect Operating, LLC |
|---|---|
| FDA product code | QJJ |
| Device type | Indirect Bonding Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2024-02-02 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REF06 | 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 |
| 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.