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 Implant System	UF 4510S	FDA UDI	Class II	Unknown
Pre-milled Bar	CBMC 02H	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 4815	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	API 60714	FDA UDI	Class I	Active
DIO Guide Sinus Approach Stopper	GST 11RD	FDA UDI	Class I	Active
DIOnavi. Implant Connector	GNIC 3612ST R	FDA UDI	Class I	Active
Cemented Abutment	AMI 35017N[H]	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4815T(II)	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PSWF 6010S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 3914	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 60649	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SASA 5804	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 4510UV3	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 75405	FDA UDI	Class II	Active
UFIII Fixture	UFIII 3810S	FDA UDI	Class II	Active
UF(II) Internal Guide	INT 11H	FDA UDI	Class I	Active
DIO Sinus Approach Stopper	ST 05RD	FDA UDI	Class I	Active
UF(II) Implant System	DASC 2008H	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUN 4555N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75454	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4515H	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 5511SF	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4508S	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DUR 1570H	FDA UDI	Class II	Unknown
DIO Fixture Removing Driver	NFRD 11S<VerA>	FDA UDI	Class I	Active
DIO Screw Driver	MD 0522L	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 6503N	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DCN 3570N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55107H(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	PSI 4814P	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75104H(II)	FDA UDI	Class II	Active
UFIII Fixture	UFIII 4008S	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55307H(II)	FDA UDI	Class II	Active
FTN Fixture Driver	HGC 4020	FDA UDI	Class I	Active
UF Implant System	UF 4015S	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 10 A03(a,b)	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4310	FDA UDI	Class I	Active
DIOnavi. Guide sleeve	GSL 36YESET	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 50603	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 45304	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 3813SF	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAP 5510B	FDA UDI	Class II	Unknown
DIOnavi. Guide Sleeve	GSCS 36YE_50	FDA UDI	Class I	Active
DIO Straight Drill	DSU 5415M	FDA UDI	Class I	Active
DIO Guide Sinus Approach Stopper	GST 07YE	FDA UDI	Class I	Active
Protem Straight Drill	MSD 1512	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCR 2555H	FDA UDI	Class II	Unknown
UF(II) Narrow Pick-up Impression Coping	UNSPI 4016N	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75355	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SMA 5515T	FDA UDI	Class II	Unknown

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