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
UF(II) Anatomic abutment	DLN 4570H	FDA UDI	Class II	Unknown
UF(II) Narrow Ball Abutment Analog	UNSBAA 3510	FDA UDI	Class I	Active
DIO H-Scan Body	ITHSB 481	FDA UDI	Class I	Active
DIO Steady External Implant System	ETF 6016R	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 3807S	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAS 3948	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SMA 4514N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75507	FDA UDI	Class II	Active
UF(II) Eco Cemented Post	USPN 4807N	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCS 2720	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5815N(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSMA 5525N	FDA UDI	Class II	Unknown
Secure Implant System	MFB 30216A	FDA UDI	Class II	Active
DIO Straight Drill	DSU 6011	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 45507	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTA 4510N	FDA UDI	Class II	Unknown
Dio Implant Systems	AEI 35037	FDA UDI	Class II	Unknown
DIOnavi-P. MAX	3DCNBF-1000A3<VerA>	FDA UDI	Class I	Active
UF(II) Internal Pick-up Impression Coping	IPI 60008Y	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAS 3964	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6864T(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40207N	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCS 2710S	FDA UDI	Class II	Active
FTN H-Scan Body	ENHSB 481H	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4013S	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSAA 402015BH	FDA UDI	Class II	Active
UF(II) Healing Cap Screw	MHCSC 1604	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SASP 5810B	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 11 A05(a,b)	FDA UDI	Class I	Active
FTN Fixture Mount	MAN 5007-1	FDA UDI	Class I	Active
DIOnavi. Abutment Profile Drill	UAPD 5822<VerA>	FDA UDI	Class I	Active
DIO Water Membrane Lifter	WML 6627	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 11	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSMUA 483020H	FDA UDI	Class II	Active
DIO H-Scan Body	ITHSB 681	FDA UDI	Class I	Active
DIO Scan Adapter	SCAN 18-15[H]	FDA UDI	Class I	Active
DIO Steady External Implant System	ETF 4010R	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 25214	FDA UDI	Class II	Unknown
Dio Sm Implant System	SAHN 4136	FDA UDI	Class II	Unknown
UF(II) Narrow Protect Cap	DACCN 70	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 13 A02(a,b)	FDA UDI	Class I	Active
UF Implant System	PUF(II) 4507S	FDA UDI	Class II	Unknown
UF Implant System	UF 4007S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ACN 50634	FDA UDI	Class II	Unknown
DIO Reamer Set	IR 48	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUR 5570H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SHN 2011S	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 65204H(II)	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	SHN 1404	FDA UDI	Class II	Unknown
UF Implant System	PUF(II) 5011S	FDA UDI	Class II	Unknown

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