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 IDK203688
510k NumberK203688
Device Name:Clear Aligner
ClassificationAligner, Sequential
Applicant Wuxi EA Medical Instruments Technologies Limited. No. 1619, Huishan Avenue, Huishan Economic Development Zone Wuxi,  CN 214174
ContactYan He
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-17
Decision Date2021-10-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06956748700495 K203688 000

Trademark Results [Clear Aligner]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEAR ALIGNER
CLEAR ALIGNER
78372947 not registered Dead/Abandoned
Kim, Tae-Weon
2004-02-24

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