Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K200193 |
Device Name |
Kisses Plus Implant System |
Applicant |
ACHIMHAI Medical Corporation |
28, Namyang-ro, 930beon-gil, Namyang-eup |
Hwaseong-si,
KR
18255
|
|
Applicant Contact |
Ji Ho Jung |
Correspondent |
LK Consulting Group USA, Inc. |
1150 Roosevelt, STE 200 |
Irvine,
CA
92620
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 01/27/2020 |
Decision Date | 08/06/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|