Device Classification Name |
implant, endosseous, orthodontic
|
510(k) Number |
K182929 |
Device Name |
BIO-RAY A-1 Anchor Screw System |
Applicant |
Microware Precision Co., Ltd. |
No. 12, Keyuan 2nd Rd., Situn District |
Taichung,
TW
40763
|
|
Applicant Contact |
Harrison Du |
Correspondent |
Microware Precision Co., Ltd. |
No. 12, Keyuan 2nd Rd., Situn District |
Taichung,
TW
40763
|
|
Correspondent Contact |
Harrison Du |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 10/22/2018 |
Decision Date | 11/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|