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
Sm Internal/External Implant Systems	AMI 48435EX	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 11 A04(a,b)	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 10	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55305N(II)	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6864(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSMUA 485020H	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5814N(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3013SF	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3813	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 453025BH	FDA UDI	Class II	Active
UF(II) Internal Cast Abutment	CAI 4812Y	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPI 48004	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	BC 5004	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 13 A02	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 4801H	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAC 5864N	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 00 A04(a,b)	FDA UDI	Class I	Active
UFIII Fixture	UFIII 5010UV3	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 75304	FDA UDI	Class II	Unknown
UF(II) Profile Drill	UPD 6010	FDA UDI	Class I	Active
DIOnavi. Abutment Profile Drill	UAPD 5126M<VerA>	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65505N(II)	FDA UDI	Class II	Unknown
UF Implant System	UF 4507S<VerA>	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	MSD 2509D	FDA UDI	Class I	Active
DIOnavi. Profile Drill	GPD 5005M	FDA UDI	Class I	Active
UF(II) Profile Drill	UPD 4505D	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65404	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 45107N(II)	FDA UDI	Class II	Unknown
DIO Sinus Kit	DSNK 04	FDA UDI	Class I	Active
Dio Protem Implant System	MFP 20208	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DMR 2555H	FDA UDI	Class II	Unknown
FTN Scan Adapter Screw	ESSC 2008H	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 4507	FDA UDI	Class II	Unknown
UF Implant System	SWF 7014S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40640	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ACN 40534	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75255	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DLN 3570N	FDA UDI	Class II	Unknown
Temporary Cylinder	ITC 48010	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6835T(II)	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3017	FDA UDI	Class I	Active
DIOnavi. Tap Drill	GTD 5015	FDA UDI	Class I	Active
UF(II) Narrow Pick-up Impression Coping	UNSPI 4012H	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4311	FDA UDI	Class I	Active
Angled Abutment	AAN 35225[H]	FDA UDI	Class II	Active
UV Active Implant System	UF(II) 3811UV3	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 455025N	FDA UDI	Class II	Active
FTN Fixture Driver	HGC 3530	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF 4013S	FDA UDI	Class II	Unknown
UF(II) Internal Plastic Cylinder	API 60714[H]	FDA UDI	Class I	Active

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