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Invisalign System, Pre-Formed Attachment System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222894
510(k) Type
Traditional
Applicant
Align Technology, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/22/2022
Days to Decision
90 days
Submission Type
Summary

Invisalign System, Pre-Formed Attachment System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222894
510(k) Type
Traditional
Applicant
Align Technology, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/22/2022
Days to Decision
90 days
Submission Type
Summary