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BlueCheck™ Caries Detection & Monitoring

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222560
510(k) Type
Traditional
Applicant
Incisive Technologies Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
5/16/2023
Days to Decision
265 days
Submission Type
Summary

BlueCheck™ Caries Detection & Monitoring

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222560
510(k) Type
Traditional
Applicant
Incisive Technologies Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
5/16/2023
Days to Decision
265 days
Submission Type
Summary