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ULab Systems Dental Aligner Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192596
510(k) Type
Traditional
Applicant
uLab Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/2020
Days to Decision
144 days
Submission Type
Summary

ULab Systems Dental Aligner Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192596
510(k) Type
Traditional
Applicant
uLab Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/2020
Days to Decision
144 days
Submission Type
Summary