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	FFD4012	FDA UDI	Class I	Active
Implantium, Superline	DAB6535HE	FDA UDI	Class II	Active
NR Line	GIHAB5010TS	FDA UDI	Class II	Active
NR Line	GSCC52	FDA UDI	Class I	Active
Simple Line	SODTF4852N	FDA UDI	Class I	Active
Implantium, Superline	XFD5035A	FDA UDI	Class I	Active
Implantium, Superline	CIC65L(1)	FDA UDI	Class I	Active
SuperLine II	FXS4508	FDA UDI	Class II	Active
NR Line	GFX3015W	FDA UDI	Class II	Active
Implantium, Superline	CAB6545L	FDA UDI	Class II	Active
NR Line	GCAN43	FDA UDI	Class I	Active
Implantium, Superline	XHFD4835	FDA UDI	Class I	Active
NR Line	GHAB373545	FDA UDI	Class II	Active
NR Line	GRAB43CR	FDA UDI	Class II	Active
Implantium, Superline	BAB351018	FDA UDI	Class II	Active
Intra Oral Sensor	IOX2	FDA UDI	Class II	Active
Implantium, Superline	AAB255040N	FDA UDI	Class II	Active
NR Line	GDAB5530AS	FDA UDI	Class II	Active
SimpleLine II	SOHAB6520	FDA UDI	Class II	Active
Implantium, Superline	XFD3812S	FDA UDI	Class I	Active
Implantium, Superline	DPU5515HE	FDA UDI	Class I	Active
Implantium, Superline	XPP162220T	FDA UDI	Class I	Active
NR Line	GXID27H	FDA UDI	Class I	Active
Implantium, Superline	SAB4515L	FDA UDI	Class II	Active
NR Line	GRA	FDA UDI	Class I	Active
Implantium, Superline	CAB6535SL	FDA UDI	Class II	Active
NR Line	GDAB5505BAR(H)	FDA UDI	Class II	Active
Implantium, Superline	DAB65258NL	FDA UDI	Class II	Active
Implantium, Superline	AAB255020H	FDA UDI	Class II	Active
Implantium, Superline	RAB4520PNL	FDA UDI	Class I	Active
Implantium, Superline	UXNS	FDA UDI	Class I	Active
NR Line	GCMAB15AR	FDA UDI	Class II	Active
Implantium, Superline	AAB255515HL	FDA UDI	Class II	Active
Implantium, Superline	DAB5525NE	FDA UDI	Class II	Active
Implantium, Superline	XOF38B1	FDA UDI	Class I	Active
Implantium, Superline	XAD27W	FDA UDI	Class I	Active
Implantium, Superline	HAB404070L	FDA UDI	Class II	Active
Implantium, Superline	TS4447R-TR	FDA UDI	Class I	Active
Simple Line	SODBC48B	FDA UDI	Class I	Active
NR Line	GFFD4309	FDA UDI	Class I	Active
NR Line	NSJ5001R	FDA UDI	Class I	Active
Implantium, Superline	XSDAB65S	FDA UDI	Class I	Active
NR Line	GXAD15W	FDA UDI	Class I	Active
Implantium, Superline	MAB65258H	FDA UDI	Class II	Active
NR Line	GHAB651525	FDA UDI	Class II	Active
SuperLine II	FXS3610	FDA UDI	Class II	Active
Implantium, Superline	XCS4329	FDA UDI	Class I	Active
Simpleline II Abutment System	BIC3L	FDA UDI	Class II	Active
Implantium, Superline	XDS8025	FDA UDI	Class I	Active
Implantium, Superline	SFD3608	FDA UDI	Class I	Active

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