Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K193425 |
Device Name |
Pre-Milled Blank |
Applicant |
Arum Dentistry Co. Ltd |
1 Building, 44, Techno 8-ro |
Yuseong-gu, Daejeon,
KR
34028
|
|
Applicant Contact |
Hwang-Heung Yeon |
Correspondent |
Aclivi, Llc |
6455 Farley Road |
Pinckney,
MI
48169
|
|
Correspondent Contact |
Chris Brown |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 12/10/2019 |
Decision Date | 03/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|