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Pre-Milled Blank

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193425
510(k) Type
Traditional
Applicant
Arum Dentistry Co. Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
3/9/2020
Days to Decision
90 days
Submission Type
Summary

Pre-Milled Blank

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193425
510(k) Type
Traditional
Applicant
Arum Dentistry Co. Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
3/9/2020
Days to Decision
90 days
Submission Type
Summary