Last synced on 14 November 2025 at 11:06 pm

IR SLA Type Implant System

Page Type
Cleared 510(K)
510(k) Number
K222144
510(k) Type
Traditional
Applicant
Biotem Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/14/2023
Days to Decision
329 days
Submission Type
Summary

IR SLA Type Implant System

Page Type
Cleared 510(K)
510(k) Number
K222144
510(k) Type
Traditional
Applicant
Biotem Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/14/2023
Days to Decision
329 days
Submission Type
Summary