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Nightwear Aligners

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221537
510(k) Type
Traditional
Applicant
Smylio Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/5/2023
Days to Decision
313 days
Submission Type
Summary

Nightwear Aligners

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221537
510(k) Type
Traditional
Applicant
Smylio Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/5/2023
Days to Decision
313 days
Submission Type
Summary