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 Screw Driver	HD 0910A	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	PMN 50310	FDA UDI	Class I	Active
DIO Conical Abutment Driver	HD 2012A	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 455015AH	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 05	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65107N(II)	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ETF 3716R	FDA UDI	Class II	Unknown
UF(II) Eco Angled Post	USAP 550812AH	FDA UDI	Class II	Active
UF Implant System	PUF(II) 4510S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40705H	FDA UDI	Class II	Active
UF(II) Bar holder abutment	UNMBHCA 4508N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 55505	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 05 A05(a,b)	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 555025AH	FDA UDI	Class II	Active
UF(II) Internal Guide	INT 8Octa	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	PCN 50308	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 5510	FDA UDI	Class I	Active
Dio Protem Implant System	MFP 20412	FDA UDI	Class II	Active
DIO Starter Drill	SD 1530	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3010M	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 3808SF	FDA UDI	Class II	Unknown
DIO Implant Systems	PSI 4808P	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 35412	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF 4513S	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 09	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DPR 3570N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 4836T	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 3934N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40304N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55205N(II)	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 6011UV3	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHI 48604H	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 10 A04(a,b)	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	SHN 2509	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	RMI 48007EX	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 03 A01	FDA UDI	Class I	Active
DIO Implant Systems	PSI 6512P	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 2008D	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 3315S	FDA UDI	Class I	Active
DIO Straight Drill	DSU 2007M	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPN 4008N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75104H(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6015	FDA UDI	Class II	Unknown
UF(II) Internal Count Sinker	CSUI 4525	FDA UDI	Class I	Active
UF(II) Profile Drill	UPD 4505M	FDA UDI	Class I	Active
DIO Initial Drill	DHI 2014SD<VERA>	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 4015SF	FDA UDI	Class II	Active
FTN Scan Adapter	SCAN 05-15[H]	FDA UDI	Class I	Active
DIO Implant Systems	IFI 4814PM	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 5015SF	FDA UDI	Class II	Unknown

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