ECligner
Aligner, Sequential
EClear International Co., Ltd.
The following data is part of a premarket notification filed by Eclear International Co., Ltd. with the FDA for Ecligner.
Pre-market Notification Details
| Device ID | K143499 |
| 510k Number | K143499 |
| Device Name: | ECligner |
| Classification | Aligner, Sequential |
| Applicant | eClear International Co., Ltd. 30 Teheranro 27 Gil, Gangnam-gu Seoul, KP 135-915 |
| Contact | Tae Weon Kim |
| Correspondent | April Lee Withus Consulting 2531 Pepperdale Drive Rowland Heights, CA 91748 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-10 |
| Decision Date | 2015-10-09 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38800018800035 | K143499 | 000 |
Trademark Results [ECligner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ECLIGNER 85250444 4155130 Dead/Cancelled |
Kim, Tae-Weon 2011-02-24 |
 ECLIGNER 79192161 5268350 Live/Registered |
E-CLEARINTERNATIONAL CO., LTD. 2016-03-21 |
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