Device Classification Name |
Implant, Endosseous, Orthodontic
|
510(k) Number |
K202163 |
Device Name |
Mico One Orthodontic Screw |
Applicant |
Ze Fang Technology Co., Ltd. |
No.17, Aly. 81, Ln. 2, Sec. 1, Zhongxing Rd., Dali Dist., |
Taichung City, Taiwan |
Taichung,
TW
412
|
|
Applicant Contact |
Anita Chen |
Correspondent |
ZhengCheng Consulting Limited Company |
No.19, 335 Lane, Fu-Xi Road, Shulin District |
New Taipei City,
TW
238
|
|
Correspondent Contact |
Anita Chen |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 08/03/2020 |
Decision Date | 10/07/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|