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	DAUN 5555H	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 3315R	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 4508S	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 4315D	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHI 48603H	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 3310B	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65104H(II)	FDA UDI	Class II	Active
UF(II) Implant System	UNSSA 45705	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DLR 3570N	FDA UDI	Class II	Unknown
DIOnavi. Abutment Jig	AJ3D 04N	FDA UDI	Class I	Active
DIOnavi. Drill Tube	UDTE 10	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ACN 40534	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 65305N(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45507H	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3808	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 40604	FDA UDI	Class II	Active
DIOnavi. Bone Flattening Drill	UBFD 5127<VERA>	FDA UDI	Class I	Active
DIOnavi. Guide Drill	UGD 2002W<Al>	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DMR 1570H	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4826	FDA UDI	Class II	Unknown
UF(II) Pick-up Impression Coping	SSPI 6509N	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DPR 4570H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TMN 40512	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DALR 2570H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3315SF	FDA UDI	Class II	Active
UF(II) Wide	UF(II) 6007S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 7507	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75404	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	TMT 50612N	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 09 A04(a,b)	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAC 3924N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTA 4530H	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 75105	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 6510H	FDA UDI	Class II	Active
UF(II) Implant System	UNSSA 40707	FDA UDI	Class II	Active
DIO Screw Driver	HD 1210A	FDA UDI	Class I	Active
Secure Implant System	MFP 30416A	FDA UDI	Class II	Unknown
DIO External Guide	EXT 24	FDA UDI	Class I	Active
DIO Sinus Approach Stopper	ST 10YE	FDA UDI	Class I	Active
DIOnavi. Guide	GUIDE02 02(a,b)	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 4513SD	FDA UDI	Class I	Active
Multi Angled Abutment	MAA 485520H	FDA UDI	Class II	Active
Angled Abutment	AAT 50215[H]	FDA UDI	Class II	Active
DIOnavi. Abutment Profile Drill	UAPD 3428	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUN 3555H	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 4511R	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 4016S	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 4516R	FDA UDI	Class II	Unknown
UF(II) Eco Pickup Impression Coping	USPI 6506N	FDA UDI	Class I	Active
DIOnavi. Guide Sleeve	GSC 36YE_50	FDA UDI	Class I	Active

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