Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K181037 |
Device Name |
DIO CAD/CAM Abutment |
Applicant |
DIO Corporation |
66, Centum Seo-ro, Haeundae-gu |
Busan,
KR
48058
|
|
Applicant Contact |
Jiae Park |
Correspondent |
Withus Group Inc |
106 Superior |
Irvine,
CA
92620
|
|
Correspondent Contact |
April Lee |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 04/19/2018 |
Decision Date | 12/21/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|