Device Classification Name |
implant, endosseous, orthodontic
|
510(k) Number |
K191041 |
Device Name |
Orthodontic Fixation Screw [Smart Anchor Miniscrew] |
Applicant |
GNI Co., LTD |
5F 501, 63-12 Dongtancheomdansaneop 1-RO |
Hwaseong,
KR
18469
|
|
Applicant Contact |
Duk Soo Kim |
Correspondent |
E&M Consulting |
D-1474ho, 230 Simin-daero, Dongan-gu |
Anyang,
KR
14067
|
|
Correspondent Contact |
Sang Hwa Myung |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 04/19/2019 |
Decision Date | 08/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|