Clear Aligner
Aligner, Sequential
Wuxi EA Medical Instruments Technologies Limited.
The following data is part of a premarket notification filed by Wuxi Ea Medical Instruments Technologies Limited. with the FDA for Clear Aligner.
Pre-market Notification Details
| Device ID | K203688 |
| 510k Number | K203688 |
| Device Name: | Clear Aligner |
| Classification | Aligner, Sequential |
| Applicant | Wuxi EA Medical Instruments Technologies Limited. No. 1619, Huishan Avenue, Huishan Economic Development Zone Wuxi, CN 214174 |
| Contact | Yan He |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-17 |
| Decision Date | 2021-10-08 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06956748700495 | K203688 | 000 |
Trademark Results [Clear Aligner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEAR ALIGNER 78372947 not registered Dead/Abandoned |
Kim, Tae-Weon 2004-02-24 |
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