Device Classification Name |
Resin, Root Canal Filling
|
510(k) Number |
K190503 |
Device Name |
CeraSeal |
Applicant |
Meta Biomed Co., Ltd. |
270, Osong Saengmyeong 1-ro |
Osong-eup, Heungdeok-gu |
Cheongju-si,
KR
28161
|
|
Applicant Contact |
Suk Song Oh |
Correspondent |
Withus Group Inc |
106 Superior |
Irvine,
CA
92620
|
|
Correspondent Contact |
April Lee |
Regulation Number | 872.3820
|
Classification Product Code |
|
Date Received | 03/01/2019 |
Decision Date | 06/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|