Itero Articulator Kit
Catalogue number 107806, listed by Align Technology, Inc., United States, under Articulators. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
| Dongguan Yilong Medical Supplies Co.. Ltd. | Dongguan | Guangdong | Contract manufacturer | 8 |
| Topway Dental Laboratory Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Align Technology, Inc., United States |
|---|---|
| FDA product code | EJP |
| Device type | Articulators |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-04 |
| Record revised | 2023-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 107806 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Handy IIM | Shofu Dental Corp. | 6 |
| Hanau modular Articulator | Whip-MIX Corp. | 5 |
| W.O.W.™ | Premier Dental Products Co. | 4 |
| Denar Mark 320 Articulator | Whip-MIX Corp. | 2 |
| Denar Mark 310 Articulator | Whip-MIX Corp. | 2 |
| 2240 Q Articulator | Whip-MIX Corp. | 2 |
| Denar Mark 330 Articulator | Whip-MIX Corp. | 2 |
| 4641 Articulator | Whip-MIX Corp. | 1 |
| Arcus | Kavo Dental Gmbh | 1 |
| Hanau-Mate Non-Adjustable Articulator | Whip-MIX Corp. | 1 |
| Hanau Wide-Vue Articulator | Whip-MIX Corp. | 1 |
| D5A Fully-Adjustable Articulator | Whip-MIX Corp. | 1 |
Showing 12 of 34. All products under Articulators
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.