Astek
Impression Tray Upper Right / Lower Left (25) #7 Unodent
73manufacturers in China registered for this device type
102catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (17), Shanghai (11), Jiangsu (10). 14 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 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Cixi Qimei Combination Tool Packing Factory | Cixi | Shanghai | Contract manufacturer | 10 |
| Yongqing Huaguan Dental Instruments Factory | Langfang | Hebei | Contract manufacturer | 9 |
Showing 12 of 73. All 73 manufacturers in China registered for Tray, Impression, Preformed
Record
| Listed by | Young Innovations Inc., United States |
|---|---|
| FDA product code | EHY |
| Device type | Tray, Impression, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6880 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-31 |
| Record revised | 2025-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20, case of 15, bag of 50, bag of 25, package of 12, inner pack of 12 |
| Distribution end date | 2023-05-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 117151 | In distribution | |
| 118212 | In distribution | |
| 116128 | In distribution | |
| 116130UNODENT | In distribution | |
| 116132 | In distribution | |
| 117152UNODENT | In distribution | |
| 116140UNODENT | In distribution | |
| 117146 | In distribution | |
| 116139 | In distribution | |
| 114142 | In distribution | |
| 116129UNODENT | In distribution | |
| 116140 | In distribution | |
| 117141 | In distribution | |
| 117146UNODENT | In distribution | |
| 117147 | In distribution | |
| 117148UNODENT | In distribution | |
| 118242 | In distribution | |
| 114143 | In distribution | |
| 116133 | In distribution | |
| 116126UNODENT | In distribution | |
| 116130 | In distribution | |
| 118243 | In distribution | |
| 116127UNODENT | In distribution | |
| 118244 | In distribution | |
| 117151UNODENT | In distribution | |
| 116131UNODENT | In distribution | |
| 116128UNODENT | In distribution | |
| 118213 | In distribution | |
| 114141 | In distribution | |
| 117142 | In distribution | |
| 118201 | In distribution | |
| 114143UNODENT | In distribution | |
| 116125UNODENT | In distribution | |
| 118207 | In distribution | |
| 114142UNODENT | In distribution | |
| 118211 | In distribution | |
| 118245 | In distribution | |
| 114141UNODENT | In distribution | |
| 116126 | In distribution | |
| 117145UNODENT | In distribution | |
| 117141UNODENT | In distribution | |
| 118249 | In distribution | |
| 118248 | In distribution | |
| 117143 | In distribution | |
| 118208 | In distribution | |
| 118202 | In distribution | |
| 117142UNODENT | In distribution | |
| 117149UNODENT | In distribution | |
| 118205 | In distribution | |
| 118204 | In distribution | |
| 116131 | In distribution | |
| 116125 | In distribution | |
| 117140UNODENT | In distribution | |
| 118252 | In distribution | |
| 117144UNODENT | In distribution | |
| 117150UNODENT | In distribution | |
| 117145 | In distribution | |
| 117154UNODENT | In distribution | |
| 118210 | In distribution | |
| 118209 | In distribution | |
| 116133UNODENT | In distribution | |
| 116139UNODENT | In distribution | |
| 117140 | In distribution | |
| 117149 | In distribution | |
| 117147UNODENT | In distribution | |
| 118251 | In distribution | |
| 118250 | In distribution | |
| 117152 | In distribution | |
| 116127 | In distribution | |
| 118241 | In distribution | |
| 118247 | In distribution | |
| 116132UNODENT | In distribution | |
| 116129 | In distribution | |
| 117150 | In distribution | |
| 118203 | In distribution | |
| 117154 | In distribution | |
| 118206 | In distribution | |
| 116124 | In distribution | |
| 118214 | In distribution | |
| 118200 | In distribution | |
| 117153UNODENT | In distribution | |
| 118246 | In distribution | |
| 117148 | In distribution | |
| 117144 | In distribution | |
| 116124UNODENT | In distribution | |
| 117153 | In distribution | |
| 117143UNODENT | In distribution | |
| 118204 | Withdrawn | |
| 118201 | Withdrawn | |
| 118211 | Withdrawn | |
| 118203 | Withdrawn | |
| 118202 | Withdrawn | |
| 118200 | Withdrawn | |
| 118213 | Withdrawn | |
| 118206 | Withdrawn | |
| 118207 | Withdrawn | |
| 118209 | Withdrawn | |
| 118212 | Withdrawn | |
| 118205 | Withdrawn | |
| 118214 | Withdrawn | |
| 118208 | Withdrawn | |
| 118210 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OneBite Evolution | Precision Dental Products, LLC | 114 |
| Benco | Benco Dental Supply Co. | 63 |
| Osung MND | Osung MND Co., Ltd. | 56 |
| Premium Plus | Premium Plus (Dongguan) Limited | 54 |
| devemed | Devemed Gmbh | 47 |
| Reicodent | Devemed Gmbh | 47 |
| Blue Sky Bio, LLC | Blue SKY BIO, LLC | 47 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 45 |
| Tray, Impression, Preformed | YDM Corporation | 42 |
| Premium Plus | Premium Plus International Limited | 41 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 31 |
| The Orthodontic Store | Young Innovations Inc. | 27 |
Showing 12 of 595. All products under Tray, Impression, Preformed
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.