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) Anatomic abutment	DLR 5555H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75504	FDA UDI	Class II	Active
DIO Straight Drill	DSU 5508	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ACN 40545	FDA UDI	Class II	Active
DIO Strauman Scan Adapter	SCAN 13-15[H]	FDA UDI	Class I	Active
FTN Fixture Driver	HGC 4035	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 01 A01(a,b)	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAP 6510B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RMI 48004N	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40507N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 7864(II)	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 4016R	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 55455	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	API 48514N	FDA UDI	Class II	Unknown
Veltz-C&B	3DCNB-1000A1<VerA>	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65104	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 3818D	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSSA 45704	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 6504N	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 60649	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45505H	FDA UDI	Class II	Active
DIOnavi. Profile Drill	GPD 3005M	FDA UDI	Class I	Active
DIO Straight Drill	DSU 5507	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSGA 4510N	FDA UDI	Class II	Unknown
DIO Screw Driver	MD 1719L	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DPR 4555N	FDA UDI	Class II	Unknown
UF(II) Eco Angled Post	USAP 450818BH	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SSC 3520	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45504N	FDA UDI	Class II	Active
UF(II) Fixture	UF(II) 5005UV3	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 13 A05	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 5503N	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 08 A05(a,b)	FDA UDI	Class I	Active
UF(II) Eco Bite Impression Coping	USBI 4804H	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 2715M	FDA UDI	Class I	Active
UF(II) Eco Transfer Impression Coping	USTI 4810H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	APN 40514	FDA UDI	Class II	Unknown
UF(II) Narrow Plastic Coping	UNSAP 4010B	FDA UDI	Class I	Active
UF(II) Pick-up Impression Coping	SSPI 5513H	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 3555H	FDA UDI	Class II	Unknown
UF Implant System	UF(II) 5511S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75205N(II)	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AAN 50215	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75104	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 12 A05	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6508S	FDA UDI	Class II	Active
UF(II) Scan Adapter	SCAN 5121H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 50604	FDA UDI	Class II	Active
DIOnavi. Bone Flattening Drill	UBFD 7126	FDA UDI	Class I	Active
CCM Cylinder	MCCM 5005H	FDA UDI	Class II	Unknown

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