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 Sm Implant System	SAHN 5224	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4515S	FDA UDI	Class II	Active
DIOnavi. Abutment Profile Drill	UAPD 5123M<VerA>	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4834N(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5848	FDA UDI	Class II	Unknown
DIO Screw Driver	HD 0915A	FDA UDI	Class I	Active
UV Active Implant System	UF(II)N 3010UV3	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6525	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DPR 3540N	FDA UDI	Class II	Unknown
DIO Master Kit	UF 05<VerH>	FDA UDI	Class I	Active
DIO Implant Systems	FSN 5013B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHN 40608	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 03 A03	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 40603	FDA UDI	Class II	Active
UF Implant System	UF(II) 5008S	FDA UDI	Class II	Unknown
DIO Implant System	FTN 4011B	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 65307	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45107N(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45605N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCS 2700	FDA UDI	Class II	Active
DIO Straight Drill	DSU 5515	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 55107	FDA UDI	Class II	Active
UF(II) Narrow Solid Abutment Analog	UNSSAA 4005	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55407H(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSHA 4024	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 65307N(II)	FDA UDI	Class II	Unknown
UF(II) Starter Kit	UFST 00<VerA>	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75107H(II)	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3207	FDA UDI	Class I	Active
DIO Guide Sinus Approach Stopper	GST 08RD	FDA UDI	Class I	Active
FTN Fixture Mount	EMR 4008[T]	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65205	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3807M	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SSC 3510	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 45304	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45307N(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 5025	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DCN 4555N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUR 1555H	FDA UDI	Class II	Unknown
DIO Implant System	IFI 4812PM	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45207	FDA UDI	Class II	Active
DIO Implant Systems	FSN 5511B	FDA UDI	Class II	Unknown
Protem Straight Drill	MSD 2018	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPI 48012	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75305H(II)	FDA UDI	Class II	Active
Secure Implant System	MFP 30212A	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 5008R	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6845N(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SSC 2008	FDA UDI	Class II	Active
UF Implant System	UF(II) 5518S	FDA UDI	Class II	Unknown

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