Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K191634 |
Device Name |
Scan Abutments and Comfort Caps |
Applicant |
Dentium Co., Ltd. |
150, Eondong-ro, Giheung-gu |
Yongin-si,
KR
446-914
|
|
Applicant Contact |
Byung-sun Kim |
Correspondent |
Dentium Co., Ltd. |
150, Eondong-ro, Giheung-gu |
Yongin-si,
KR
446-914
|
|
Correspondent Contact |
Byung-sun Kim |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 06/19/2019 |
Decision Date | 11/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|