Last synced on 6 December 2024 at 11:05 pm

iTero Lumina™ Pro

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240573
510(k) Type
Traditional
Applicant
Align Technology Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
8/16/2024
Days to Decision
168 days
Submission Type
Summary

iTero Lumina™ Pro

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240573
510(k) Type
Traditional
Applicant
Align Technology Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
8/16/2024
Days to Decision
168 days
Submission Type
Summary