Last synced on 18 April 2025 at 11:05 pm

BLUEDIAMOND IMPLANT, Abutment Screw

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211812
510(k) Type
Traditional
Applicant
MegaGen Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/6/2023
Days to Decision
574 days
Submission Type
Summary

BLUEDIAMOND IMPLANT, Abutment Screw

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211812
510(k) Type
Traditional
Applicant
MegaGen Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/6/2023
Days to Decision
574 days
Submission Type
Summary