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) Narrow Implant System	UNSHA 4060	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45205N	FDA UDI	Class II	Active
UFIII Fixture	UFIII 4508S	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 14 A01(a,b)	FDA UDI	Class I	Active
UF(II) Implant System	MSA 4802	FDA UDI	Class II	Active
UF Implant System	UF 4010S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75505	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6825N(II)	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 4513S	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4511S	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAH 6235	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 4516S	FDA UDI	Class II	Unknown
FTN Fixture Mount	EMT 50210[H]	FDA UDI	Class I	Active
Dio Protem Implant System	MFB 20214	FDA UDI	Class II	Unknown
UF Implant System	UF(II) 5007S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 58325B	FDA UDI	Class II	Unknown
FTN Scan Adapter Screw	ESSC 2010H	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65305	FDA UDI	Class II	Active
DIO Ball Abutment Driver	HD 2412A	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DLN 2555N	FDA UDI	Class II	Unknown
DIO Implant System	PSI 3508P	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 03 A02	FDA UDI	Class I	Active
DIO Straight Drill	DSU 5413M	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 40508	FDA UDI	Class II	Active
DIO Straight Drill	DSU 4810M	FDA UDI	Class I	Active
Dio Protem Implant System	MFP 25210	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	TMN 50612N	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSHA 4547	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 5510DW	FDA UDI	Class I	Active
DIOnavi. Drill Tube	UDTL 20	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DALR 3570H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55105N(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	RCI 60014	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 3708R	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 4013UV3	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 65309	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USPN 6507N	FDA UDI	Class II	Active
DIO Implant Systems	FSN 6011B	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 5510SF	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 4866N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4866	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 3570H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 552025N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 5824T	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 3708R	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DUN 2570H	FDA UDI	Class II	Unknown
DIO Master Kit	UF(M) 05<VerK>	FDA UDI	Class I	Active
UF(II) Eco H-Scan Body	USNHCD 4204H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	CHT 5001	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	RMI 48007N	FDA UDI	Class I	Active

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