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) Narrow Implant System	UNSHA 4520	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 6504	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 50620N	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 4308M	FDA UDI	Class I	Active
UF(II) Ratchet Screw Driver	MHD 1215A	FDA UDI	Class I	Active
DIO Round Drill	GSRD 2819	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	APN 40514S	FDA UDI	Class II	Active
Extension Cemented Abutment	AEI 48017[H]	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 6547	FDA UDI	Class II	Active
DIO Steady External Implant System	PETF 3711R	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 555025BH	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACR 3570H	FDA UDI	Class II	Unknown
FTN Fixture Mount Screw	MAN 4007-2	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSBA 3560	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7825T(II)	FDA UDI	Class II	Unknown
SM-Extra Wide Implant System	MX 5908	FDA UDI	Class II	Unknown
FTN H-Scan Body	ENHSB 441H	FDA UDI	Class I	Active
DIO Screw Driver	HD 1720A	FDA UDI	Class I	Active
DIO Implant Systems	IFI 4010PM	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6834N(II)	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5007S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 552015N	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 4011R	FDA UDI	Class II	Unknown
DIO Fixture Removing Driver	NFRD 11L<VerA>	FDA UDI	Class I	Active
FTN Scan Adapter Screw	ESSC 2506H	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75507N(II)	FDA UDI	Class II	Active
FTN Scan Adapter	SCAN 05[H]	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	RMN 50512	FDA UDI	Class II	Unknown
UF(II) Narrow Fixture Analog	UNSFA 3012	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSMUA 483020H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45105	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 4511S	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUR 3555H	FDA UDI	Class II	Unknown
UF(II) Narrow H-Scan Body	UNHSB 412H	FDA UDI	Class I	Active
DIO Megagen Scan Adapter	SCAN 19-15[H]	FDA UDI	Class I	Active
DIO H-Scan Body	ITHSB 661	FDA UDI	Class I	Active
UF(II) Narrow Solid Abutment Analog	UNSSAA 4505	FDA UDI	Class I	Active
DIO Screw Driver	MD 0530L	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7825N(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 48588	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSSA 40704	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 7505	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 6535	FDA UDI	Class II	Active
Bent Tweezer	MIT 07	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 3816S	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALR 5570H	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DMR 2540N	FDA UDI	Class II	Unknown
DIOnavi. Abutment Profile Drill	UAPD 5126<VerA>	FDA UDI	Class I	Active
DIO Steady External Implant System	ESF 3711R	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 3715R	FDA UDI	Class II	Unknown

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