Last synced on 25 January 2026 at 3:41 am

NB 1 SA Implant System

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213506
510(k) Type
Traditional
Applicant
Arum Dentistry Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
4/6/2022
Days to Decision
156 days
Submission Type
Summary

NB 1 SA Implant System

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213506
510(k) Type
Traditional
Applicant
Arum Dentistry Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
4/6/2022
Days to Decision
156 days
Submission Type
Summary