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SuperLine

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160965
510(k) Type
Abbreviated
Applicant
DENTIUM CO., LTD.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/13/2017
Days to Decision
282 days
Submission Type
Statement

SuperLine

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160965
510(k) Type
Abbreviated
Applicant
DENTIUM CO., LTD.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/13/2017
Days to Decision
282 days
Submission Type
Statement