Question 1

What types of medical devices does Dentium Co., Ltd. primarily manufacture?

Accepted Answer

Dentium Co., Ltd. specializes in dental devices, including permanent and temporary preformed dental implant suprastructures, two-piece screw endosteal dental implants, and reusable surgical kits for dental procedures. Their portfolio also covers reusable dental tools like drill bits, manual instrument handles, soft-tissue punches, and digital panoramic/tomographic X-ray systems. These products focus on dental restoration, surgical support, and diagnostic imaging.

Question 2

Where is Dentium Co., Ltd. based, and how does this affect its regulatory oversight?

Accepted Answer

Dentium Co., Ltd. is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies their products as either Class I (generally low-risk) or Class II (requiring special controls to ensure safety and effectiveness), depending on the specific device and its intended use. This classification determines the regulatory pathway for authorization.

Question 3

Are Dentium Co., Ltd.’s devices listed in any regulatory registries, and why does this matter?

Accepted Answer

Yes, Dentium Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and manufacturers to track devices throughout their lifecycle. Listing in the UDI database is a requirement for Class II devices and helps streamline post-market surveillance and compliance efforts.

Question 4

How are Dentium Co., Ltd.’s dental implant devices classified under FDA regulations?

Accepted Answer

Dentium Co., Ltd.’s dental implant devices, such as their two-piece screw endosteal implants and suprastructures, are classified under FDA’s Class I or Class II categories. Class II classification applies to implants due to their role in supporting critical bodily functions (e.g., chewing) and the need for special controls to mitigate risks like infection or improper placement. This classification ensures rigorous evaluation before authorization.

Question 5

What kinds of dental imaging equipment does Dentium Co., Ltd. produce, and how does it fit into their broader product line?

Accepted Answer

Dentium Co., Ltd. manufactures stationary panoramic/tomographic dental X-ray systems, which are digital imaging devices used for capturing detailed 3D images of a patient’s jaw, teeth, and surrounding structures. These systems complement their broader product line by providing diagnostic tools for planning dental implant procedures, assessing bone structure, and monitoring treatment progress. Like their other devices, they are designed for dental professionals.

Device	Model / Reference	Registries	Class	Status
Implantium, Superline	XPP203120	FDA UDI	Class I	Active
Implantium, Superline	DAB4525HT	FDA UDI	Class II	Active
Implantium, Superline	DPU4011NE	FDA UDI	Class I	Active
NR Line	GDAB6550AS(H)	FDA UDI	Class II	Active
Implantium, Superline	FFD4512	FDA UDI	Class I	Active
NR Line	GDAB5530AR(H)	FDA UDI	Class II	Active
Implantium, Superline	HAB483050	FDA UDI	Class II	Active
Implantium, Superline	CAB4515L	FDA UDI	Class II	Active
Implantium, Superline	DTF6511NL	FDA UDI	Class I	Active
NR Line	GIHAB4006R	FDA UDI	Class II	Active
Angled screw abutment	ASA55301518N	FDA UDI	Class II	Active
Implantium, Superline	IHAB4006TN	FDA UDI	Class II	Active
NR Line	GIHAB6008TR	FDA UDI	Class II	Active
Implantium, Superline	MAB65358H	FDA UDI	Class II	Active
Implantium, Superline	DPU5515NL	FDA UDI	Class I	Active
SimpleLine II	SOCAB4818O	FDA UDI	Class II	Active
SuperLine I	FX6016SW	FDA UDI	Class II	Active
Implantium, Superline	STC55BL	FDA UDI	Class II	Active
Implantium, Superline	AAB155540NL	FDA UDI	Class II	Active
NR Line	GXIFUB	FDA UDI	Class I	Active
Implantium, Superline	FFD3612	FDA UDI	Class I	Active
NR Line	GBAB3520	FDA UDI	Class II	Active
SuperLine I	FX5008SW	FDA UDI	Class II	Active
NR Line	GFX5009W	FDA UDI	Class II	Active
Implantium, Superline	XMH	FDA UDI	Class I	Active
NR Line	GFX4308W	FDA UDI	Class II	Active
Implantium, Superline	CAB6545E	FDA UDI	Class II	Active
NR Line	NSJ5080R	FDA UDI	Class I	Active
NR Line	GIHAB4006TS	FDA UDI	Class II	Active
SimpleLine II	SOFX654812S	FDA UDI	Class II	Active
SuperLine I	FX6012SW	FDA UDI	Class II	Active
Implantium, Superline	MAB65158N	FDA UDI	Class II	Active
NR Line	GXDST09L	FDA UDI	Class I	Active
Implantium, Superline	DGAP06	FDA UDI	Class I	Active
NR Line	GFX3612W	FDA UDI	Class II	Active
NR Line	GDRG55	FDA UDI	Class I	Active
NR Line	GDAB4330AR(H)	FDA UDI	Class II	Active
Implantium, Superline	TS4447R-A2	FDA UDI	Class I	Active
Implantium, Superline	STA55B	FDA UDI	Class I	Active
Implantium, Superline	CCC65L(1)	FDA UDI	Class I	Active
Implantium, Superline	XDSK	FDA UDI	Class I	Active
NR Line	GFX4312W	FDA UDI	Class II	Active
Simple Line	SCJSH4860	FDA UDI	Class I	Active
NR Line	GFX3010	FDA UDI	Class II	Active
Implantium, Superline	DAB5535H	FDA UDI	Class II	Active
NR Line	GCMAB15ARS	FDA UDI	Class II	Active
Implantium, Superline	XFD4335	FDA UDI	Class I	Active
Implantium, Superline	ASA5520N	FDA UDI	Class II	Active
SimpleLine II	SORAB6568CO	FDA UDI	Class II	Active
NR Line	GDPU6511S	FDA UDI	Class I	Active

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