Question 1

What types of medical devices does DIO Corporation manufacture?

Accepted Answer

DIO Corporation specializes in dental implant components and related surgical tools. Their portfolio includes permanent and temporary preformed dental implant suprastructures, reusable and single-use dental fixtures like drill bits and abutment screws, endosteal dental implants (two-piece systems), guided surgery reference plates, and reusable surgical screwdrivers. These devices are designed to support dental restoration procedures, ensuring precision and compatibility with implant systems.

Question 2

Where is DIO Corporation based, and what markets do they serve?

Accepted Answer

DIO Corporation is headquartered in South Korea. Their devices are intended for use in both European and U.S. markets, as evidenced by their listings in the EUDAMED database (for EU regulatory compliance) and the FDA’s Unique Device Identifier (UDI) system (for U.S. traceability). This indicates their products meet the regulatory requirements of these regions for dental implants and surgical instruments.

Question 3

Which regulatory registries list DIO Corporation’s devices?

Accepted Answer

DIO Corporation’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s UDI system, which tracks medical devices in the United States. These listings help ensure transparency and traceability of their products in both markets, where their devices are authorised for use.

Question 4

How are DIO Corporation’s devices classified under EU regulations?

Accepted Answer

Under EU medical device regulations, DIO Corporation’s products fall into Class I, Class II, Class IIa, and Class IIb classifications. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety—for example, implant systems and guided surgery tools are typically higher-risk (Class II or IIb) due to their invasive nature and critical role in dental procedures, while reusable fixtures like drill bits may fall into lower-risk categories like Class I or IIa.

Device	Model / Reference	Registries	Class	Status
DIO H-Scan Body	ITHSB 561	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 07N	FDA UDI	Class I	Active
UF Implant System	PSWF 6010S	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 3716R	FDA UDI	Class II	Unknown
UF(II) Eco Transfer Impression Coping	USNTI 4010N	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	TCN 40512	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSBA 3540	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AMI 48355	FDA UDI	Class II	Active
DIO Steady External Implant System	ESF 3313R	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 5015S	FDA UDI	Class I	Active
DIO Torque Wrench	DTW 0060	FDA UDI	Class I	Active
DIOnavi. Abutment Profile Drill	UAPD 7121	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAB 4504	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 45604	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SSC 3506	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45305H(II)	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 3813S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40205H	FDA UDI	Class II	Active
UF(II) Fixture	UF(II) 4505UV3	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4040	FDA UDI	Class II	Active
DIO Implant System	IFI 4012M	FDA UDI	Class II	Unknown
UF Implant System	UF 4508S<VerA>	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 6008UV3	FDA UDI	Class II	Active
DIOnavi. Drill Tube	UDT 53	FDA UDI	Class I	Active
Secure Implant System	MFB 30410A	FDA UDI	Class II	Active
UF(II) Internal Count Sinker	CSUI 4520	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCS 2720	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DMR 1555N	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	MSD 2518D	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3819	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	SSN 1403	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHT 50608	FDA UDI	Class II	Active
Dio Sm Implant System	SSC 3120	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSBA 3560	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AGN 40504	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ETF 3713R	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6035	FDA UDI	Class II	Unknown
DIO Surgical Kit	UF 07<VerD>	FDA UDI	Class I	Active
DIO Sinus Round Drill	SRD 4008	FDA UDI	Class I	Active
DIOnavi. Guide sleeve	GS 53BL_50	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 06 A02	FDA UDI	Class I	Active
UF Implant System	PUF(II) 4508S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65504N(II)	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5865T(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 4013B	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	IOTI 65010	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 5824(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 48125B	FDA UDI	Class II	Unknown
SM Implant System	SFW 5312	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SHN 2009S	FDA UDI	Class II	Unknown

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