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 H-Scan Body	ITHSB 682	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	RMI 48004EX	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UF(II)N 3315SF	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFB 20210	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCS 3430S	FDA UDI	Class II	Active
DIO Steady External Implant System	PETF 5011R	FDA UDI	Class II	Unknown
FTN Fixture Driver	HGC 3524	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45405N	FDA UDI	Class II	Active
DIOnavi. Initial Drill	ISD 2019	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USPN 4805N	FDA UDI	Class II	Active
UF(II) Eco Base Abutment	USBA 6501N	FDA UDI	Class II	Active
UF Implant System	UF 5007S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ABN 40502	FDA UDI	Class II	Active
DIO Implant System	PSI 6514P	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	STI 2004	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40540	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	API 60714N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	PMN 40310	FDA UDI	Class II	Unknown
Dio Implant Systems	AMI 35037	FDA UDI	Class II	Unknown
UF(II) Narrow Internal Guide	NINT 11N	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AAT 50415	FDA UDI	Class II	Active
Secure Implant System	MFP 30412A	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55505N(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 4814M	FDA UDI	Class II	Unknown
UF Implant System	UF 5008S<VerA>	FDA UDI	Class II	Unknown
UF(II) Profile Drill	UPD 4005D	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 3308SM	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAP 4510S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 55257	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AGN 35414	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55504N(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TMN 50612N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 35412S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSCS 3420	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHN 40502	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75205	FDA UDI	Class II	Unknown
FTN Scan Adapter	SCAN 06-15[H]	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DACN 2570N	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 6013S	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DLR 4555N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALR 1570H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPN 50608N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 55457	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75404H(II)	FDA UDI	Class II	Active
DIOnavi. Guide	GUIDE02 07(a,b)	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45404H(II)	FDA UDI	Class II	Active
Protem Straight Drill	MSD 2018M	FDA UDI	Class I	Active
DIOnavi. Abutment Profile Drill	UAPD 5124M	FDA UDI	Class I	Active
Temporary Cylinder	MTEM 5412N	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 65305	FDA UDI	Class II	Unknown

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