Device Classification Name |
Powder, Porcelain
|
510(k) Number |
K211308 |
Device Name |
INNI-CERA |
Applicant |
Aon Co., Ltd |
A-Dong 2508,2201, 17, Gosan-ro 148beon-gil |
Gunpo,
KR
15850
|
|
Applicant Contact |
Julie Choi |
Correspondent |
E&M |
D-1474, 230, Simin-daero, Dongan-gu |
Anyang,
KR
14067
|
|
Correspondent Contact |
Sanghwa Myung |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 04/29/2021 |
Decision Date | 10/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|