Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K193404 |
Device Name |
UF(II) Bar holder abutment |
Applicant |
DIO Corporation |
66, Centumseo-ro, Haeundae-gu, |
Busan,
KR
48058
|
|
Applicant Contact |
JiAe Park |
Correspondent |
Provision Consulting Group Inc. |
100 N. Barranca Street, |
Suite 700 |
West Covina,
CA
91791
|
|
Correspondent Contact |
Joyce Kwon |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 12/06/2019 |
Decision Date | 05/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|