The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Dental Electric Motor.
| Device ID | K203706 |
| 510k Number | K203706 |
| Device Name: | Dental Electric Motor |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin, CN 541004 |
| Contact | Jiakang Ning |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, CN |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2022-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944843611563 | K203706 | 000 |
| 06944843655833 | K203706 | 000 |
| 06944843655840 | K203706 | 000 |
| 06944843655857 | K203706 | 000 |
| 06944843655864 | K203706 | 000 |
| 06944843655871 | K203706 | 000 |
| 06944843655888 | K203706 | 000 |
| 06944843655895 | K203706 | 000 |
| 06944843605173 | K203706 | 000 |
| 06944843605395 | K203706 | 000 |
| 06944843611259 | K203706 | 000 |
| 06944843611488 | K203706 | 000 |
| 06944843611518 | K203706 | 000 |
| 06944843655826 | K203706 | 000 |