Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K223395 |
Device Name |
Luna Dental Implant System |
Applicant |
Shinhung MST Co., Ltd |
110-2, Donghwagongdan-ro, Munmak-Eup |
Wonju-Si,
KR
26365
|
|
Applicant Contact |
Sun Ho Lee |
Correspondent |
Lk Consulting Group USA, Inc |
18881 Von Karman, STE 160 |
IRVINE,
CA
92612
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/08/2022 |
Decision Date | 02/03/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|