Device Classification Name |
implant, endosseous, orthodontic
|
510(k) Number |
K173623 |
Device Name |
Anchor plate |
Applicant |
BioMaterials Korea, Inc |
#413, #329, #331 150, Jojeong-daero |
Hanam-si,
KR
12930
|
|
Applicant Contact |
Jiyea Kim |
Correspondent |
Regulatory Insight, Inc |
#413, #329, #331 150, Jojeong-daero, Hanam-si |
Gyeonggi-do,
KR
12930
|
|
Correspondent Contact |
Jiyea Kim |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 11/24/2017 |
Decision Date | 08/30/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|