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-Extra Wide(rbm) Implant Systems	SAH 5236	FDA UDI	Class II	Unknown
Protem Fixture Driver	MGC 3515	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 40606	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40204N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 454015BH	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 4016R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45204N	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	SHN 2008S	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DUN 2570N	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2518DN	FDA UDI	Class I	Active
DIOnavi. Profile Drill	GPD 3305	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DLN 2570N	FDA UDI	Class II	Unknown
DIO Pick-up Impression Coping	NPI 3810	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65304	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3811	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 09 A05	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 35403	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40107H	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUN 1555N	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	SWF 6010S	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALR 5555N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65505H(II)	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 5013SM	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTA 4530H	FDA UDI	Class II	Unknown
Dio Implant Systems	AAI 35015NA	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AMT 50639	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4513	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5507S	FDA UDI	Class II	Active
DIO STEADY External Implant System	ETF 6011R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65205N(II)	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 05 A04	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 551515BH	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACN 1555H	FDA UDI	Class II	Unknown
Fixture Mount	EMN 35210	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55404H(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40207N	FDA UDI	Class II	Unknown
DIO Slot Driver	HD 0615A	FDA UDI	Class I	Active
UF(II) Internal Cast Abutment	CAI 6012N	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75107H(II)	FDA UDI	Class II	Active
UF(II) Scan Adapter	SCAN 581H	FDA UDI	Class I	Active
Secure Implant System(2.5/3.0mm)	MHC 5006	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4234	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	HCN 40504	FDA UDI	Class II	Unknown
DIO Screw Driver	MD 0930	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 55105	FDA UDI	Class II	Unknown
DIOnavi. Abutment Profile Drill	UAPD 5126M	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75104N(II)	FDA UDI	Class II	Unknown
DIO Drill Stopper	ST 3300F	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSHA 4535	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5510S	FDA UDI	Class II	Active

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