TPLC - Total Product Life Cycle

• 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
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

MDR Year	MDR Reports	MDR Events
2020	38	26
2021	68	53
2022	84	84
2023	78	78
2024	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Osseointegrate	244	219
Loss of Osseointegration	13	11
Fracture	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Detachment of Device or Device Component	2	2
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	124	110
Fibrosis	113	101
Pain	20	19
Unspecified Infection	17	15
Tissue Damage	16	15
Inflammation	15	15
Hemorrhage/Bleeding	10	9
Swelling/ Edema	10	8
Failure of Implant	6	0
Inadequate Osseointegration	3	0
Hypersensitivity/Allergic reaction	2	2
Insufficient Information	2	2
Increased Sensitivity	2	2
Fistula	1	1