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Custom-made Invisible Aligners

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223454
510(k) Type
Traditional
Applicant
Zhejiang Yinchili Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/17/2023
Days to Decision
152 days
Submission Type
Summary

Custom-made Invisible Aligners

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223454
510(k) Type
Traditional
Applicant
Zhejiang Yinchili Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/17/2023
Days to Decision
152 days
Submission Type
Summary