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Osstem Abutment System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182091
510(k) Type
Traditional
Applicant
Osstem Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
7/12/2019
Days to Decision
343 days
Submission Type
Summary

Osstem Abutment System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182091
510(k) Type
Traditional
Applicant
Osstem Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
7/12/2019
Days to Decision
343 days
Submission Type
Summary