MED610
MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The…
MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays. MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose. MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity.
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 | Stratasys Ltd, Israel |
|---|---|
| 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 | 2024-01-10 |
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 | Storage environment temperature 60 to 77 °F; Storage environment temperature 15 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MED610 1.1Kg | In distribution | |
| MED610 4Kg | In distribution | |
| MED610 3.6Kg | In distribution | |
| MED610 1Kg | In distribution | |
| MED610 4kg (J5 DentaJet) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LuxaPrint Ortho Flex 385 | DMG Digital Enterprises SE | 8 |
| 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 |
| 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.