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) Eco Base Abutment	USBA 5501N	FDA UDI	Class II	Active
DIO Guide Drill	GD 1833M	FDA UDI	Class I	Active
DIOnavi. Point Straight Drill	PSD 2525	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45105N(II)	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	IPI 60710N	FDA UDI	Class I	Active
DIO Implant Systems	PSI 4008	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ABN 35502	FDA UDI	Class II	Unknown
UF(II) Eco Bite Impression Coping	USBI 6504H	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4308	FDA UDI	Class I	Active
UF Implant System	UF 3815S	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 40607	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 45304H(II)	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 02 A02	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 05 A03(a,b)	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3210M	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 6515S	FDA UDI	Class II	Unknown
DIO Sinus Approach Bone Condenser	SBC 2533	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 6015R	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 7817(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAI 35015A	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4016SF	FDA UDI	Class II	Active
DIO Sinus Approach Stopper	ST 07YE	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55105H(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 6525	FDA UDI	Class II	Unknown
UF(II) Bar holder abutment	MBHCA 4509N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALR 1555N	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 3811UV3	FDA UDI	Class II	Active
Fixture Mount	EMW 5008T	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3218	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7814T(II)	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 6507UV3	FDA UDI	Class II	Active
UF(II) Narrow Scan Adapter Screw	UNSCAN 1408H	FDA UDI	Class I	Active
DIO Steady External Implant System	PETF 4010R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSTA 4030H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45405	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40405N	FDA UDI	Class II	Active
DIO Implant Systems	FTN 4010B	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 5507SF	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 6510N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 4814(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SASC 3904	FDA UDI	Class II	Unknown
UF(II) Scan Adapter	SCAN 541H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AAN 35425	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 13 A04	FDA UDI	Class I	Active
UF Implant System	SWF 6512S	FDA UDI	Class II	Unknown
FTN Fixture Mount	EMR 4008T[T]	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 3711R	FDA UDI	Class II	Unknown
UF Implant System	PUF(II) 5013S	FDA UDI	Class II	Unknown
SM-Extra Wide Implant System	MX 6908	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 555015AH	FDA UDI	Class II	Active

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