Question 1

What types of medical devices does ARUM Dentistry Co., Ltd. manufacture?

Accepted Answer

ARUM Dentistry Co., Ltd. specializes in dental devices, primarily focusing on ceramic materials for dental appliance fabrication. Their portfolio also includes preformed suprastructures for dental implants, categorized as both temporary (single-use) and permanent solutions. Additionally, they produce two-piece screw endosteal dental implants, such as angled abutments and branded fixtures like the ARENA Star and MontBlanc. These devices are designed to support dental restoration procedures.

Question 2

Where is ARUM Dentistry Co., Ltd. based, and how does this affect its regulatory compliance?

Accepted Answer

ARUM Dentistry Co., Ltd. is based in the United States. As a U.S.-based manufacturer, the company must comply with FDA regulations governing medical devices, including classification, registration, and listing requirements. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and adherence to U.S. regulatory standards for dental implant components and abutments.

Question 3

Which regulatory registries or databases list ARUM Dentistry Co., Ltd.’s devices?

Accepted Answer

ARUM Dentistry Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices, ensuring transparency and regulatory compliance. This listing helps healthcare providers and regulators track and verify the devices’ classification and compliance status under U.S. regulations.

Question 4

How are ARUM Dentistry Co., Ltd.’s devices classified under FDA regulations?

Accepted Answer

ARUM Dentistry Co., Ltd.’s devices are classified under two categories by the FDA: Class I and Class II. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and benefits, ensuring appropriate regulatory oversight for dental implant suprastructures, abutments, and ceramic materials.

Device	Model / Reference	Registries	Class	Status
Cemented Abutment	NBAH452P	FDA UDI	Class II	Active
Cover Screw	CS2802GM	FDA UDI	Class II	Active
ARUM NB Healing Abutment	HA4009R	FDA UDI	Class II	Active
Cemented Abutment Mini	SACH4537MP	FDA UDI	Class II	Active
Cemented Abutment	SACH6567RP	FDA UDI	Class II	Active
NB Fixture Mini	NB3513SS	FDA UDI	Class II	Active
NB Cemented Abutment	SACN5547R	FDA UDI	Class II	Active
NB Fixture Mini	NB3208SS	FDA UDI	Class II	Active
Healing Abutment	HA7505GR	FDA UDI	Class II	Active
Healing Abutment	HA4506R	EUDAMEDFDA UDI	Class II	Active
NB II Fixture	NB24507SS	EUDAMEDFDA UDI	Class II	Active
Cemented Abutment Mini	SACN4535M	FDA UDI	Class II	Active
ARUM NB 1 SA Fixture	NB15508SS	FDA UDI	Class II	Active
NB I Fixture	NB15007SP	EUDAMEDFDA UDI	Class II	Active
Cemented Abutment Mini	SACH4555MP	FDA UDI	Class II	Active
NB Cemented Abutment	SACH5525R	FDA UDI	Class II	Active
Master Fix Screw	NBLS53R	FDA UDI	Class II	Active
Scan Healing Abutment	HAS7505RP	FDA UDI	Class II	Active
Cemented Abutment Mini	SACN4527M	FDA UDI	Class II	Active
Scan Healing Abutment	HAS5507R	EUDAMEDFDA UDI	Class II	Active
Cemented Abutment	NBAN653P	FDA UDI	Class II	Active
ARUM NB 1 SA Fixture	NB15506S	FDA UDI	Class II	Active
Healing Abutment	HA4510R	EUDAMEDFDA UDI	Class II	Active
Cemented Abutment	NBAN552	FDA UDI	Class II	Active

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