Last synced on 12 July 2024 at 11:04 pm

Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230237
510(k) Type
Traditional
Applicant
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/14/2023
Days to Decision
227 days
Submission Type
Statement

Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230237
510(k) Type
Traditional
Applicant
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/14/2023
Days to Decision
227 days
Submission Type
Statement