First Bite® Disposable Impression Trays
First Bite® Disposable Impression Tray Refill - Posterior (Double Arch)
73manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
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 | Dentsply LLC, United States |
|---|---|
| FDA product code | EHY |
| Device type | Tray, Impression, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6880 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight and protect from moisture. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 661204 | 30 Trays | 30 | In distribution |
| 661201 | 50 Trays | 50 | In distribution |
| 661202 | 40 Trays | 40 | In distribution |
| 661203 | 30 Trays | 30 | In distribution |
| 661207 | 50 Trays | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OneBite Evolution | Precision Dental Products, LLC | 114 |
| Astek | Young Innovations Inc. | 102 |
| 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 |
Showing 12 of 595. All products under Tray, Impression, Preformed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K801548 | 1980-07-21 |
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.