|
Device |
implant, endosseous, orthodontic |
Definition |
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. |
Product Code | OAT |
Regulation Number |
872.3640
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BIO CETEC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMATERIALS KOREA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLUE SKY BIO, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOMEI CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CRANIOFACIAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTOS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GNI CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROWARE PRECISION CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MK MEDITECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K210559 ATOZ Mini-Screw
|
OSTEONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTEC SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECHWIN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZE FANG TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|