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
DIOnavi. Straight Drill	USD 2718	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 7008S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMI 48007	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DMR 3555N	FDA UDI	Class II	Unknown
Protem O-Ring	OR 3401	FDA UDI	Class I	Active
UF Implant System	SWF 6510S	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 01 A03(a,b)	FDA UDI	Class I	Active
UF(II) Scan Adapter Screw	SSCAN 2013H	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5018S	FDA UDI	Class II	Active
FTN Surgical Kit	FTN 02	FDA UDI	Class I	Active
UCLA Plastic Abutment	APT 50613[H]	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45305H	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAS 4834	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 5010S	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFN 4112H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45107	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 4310M	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 5008R	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 00 A05(a,b)	FDA UDI	Class I	Active
DIO Megagen Pre-Milled Bar	CBMS 01[H]	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DLN 4570N	FDA UDI	Class II	Unknown
FTN Surgical Kit	FTN(M) 02-M	FDA UDI	Class I	Active
DIO Anyridge Pre-milled Bar	CBAR 02[H]	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55307N(II)	FDA UDI	Class II	Active
DIOnavi. Guide	GUIDE02 03(a,b)	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45104H	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DMR 1555H	FDA UDI	Class II	Unknown
DIO Dr. SOS Plus Kit	DRS 02	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 55405	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	API 60714N	FDA UDI	Class II	Active
UF(II) Eco Base Abutment	USBA 5505H	FDA UDI	Class II	Active
UF(II) Eco Cemented Post	USP 4505N	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 75205	FDA UDI	Class II	Active
DIOnavi-C&B Z	3DCNBF-1000A3.5	FDA UDI	Class I	Active
DIO Straight Drill	DSU 2010M<VerA>	FDA UDI	Class I	Active
DIO Implant System	PSI 3512P	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 6507S	FDA UDI	Class II	Active
UF(II) Narrow Internal Guide	NINT 11H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 40506	FDA UDI	Class II	Active
DIO Straight Drill	DSU 3008M	FDA UDI	Class I	Active
Cemented Cylinder	MCEM 5408N	FDA UDI	Class II	Active
UF(II) Angled Path Pin	DAP 4515A	FDA UDI	Class I	Active
UF Implant System	PUF(II) 5511S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 3616	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAT 50425	FDA UDI	Class II	Unknown
DIO Lateral Core Drill	SLCD 7004	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 45504	FDA UDI	Class II	Active
DIOnavi. Straight Drill	MSD 1509D	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DALR 2555H	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 39315B	FDA UDI	Class II	Unknown

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