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ITERO SOFTWARE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131101
510(k) Type
Traditional
Applicant
CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/26/2013
Days to Decision
129 days
Submission Type
Summary

ITERO SOFTWARE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131101
510(k) Type
Traditional
Applicant
CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/26/2013
Days to Decision
129 days
Submission Type
Summary