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 Steady External Implant System	PESF 3716R	FDA UDI	Class II	Unknown
FTN H-Scan Body	EWHSB 642H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPT 50612	FDA UDI	Class I	Active
DIO Drill Stopper	ST 4006	FDA UDI	Class I	Active
DIO Steady External Implant System	PESF 4516R	FDA UDI	Class II	Unknown
UF(II) Fixture	UF(II) 4005UV3	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 4834(II)	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFB 20410	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPN 40510	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USPN 4507N	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 14 A05	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DMR 3540N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSKA 4801	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 553025N	FDA UDI	Class II	Unknown
DIOnavi. Abutment Profile Drill	UAPD 5822	FDA UDI	Class I	Active
Protem Stopper Holder(2mm)	PSH 02	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCN 3555N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DACR 5570H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75304N(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	PSI 3512P	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6035	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAS 5814	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 5515H	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DACN 4555H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 7525	FDA UDI	Class II	Unknown
UF Implant System	UF 3813S<VerA>	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 02 A01	FDA UDI	Class I	Active
FTN Fixture Mount	EMN 35210[T]	FDA UDI	Class I	Active
UF(II) Bar Holder Abutment Bar	MBHAW 1680	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 3310SM	FDA UDI	Class I	Active
DIOnavi. Initial Drill	ISD 2007M<VerA>	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 65457	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 6010	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 4008R	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 6513S	FDA UDI	Class II	Unknown
Cemented Abutment	AMI 35027N[H]	FDA UDI	Class II	Active
UF(II) Eco Pickup Impression Coping	USNPI 4006H	FDA UDI	Class I	Active
Dio Ortho 3430 Tool	PSG3430	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPN 50612N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5868	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPN 5008N	FDA UDI	Class II	Unknown
Secure Implant System	MFB 30410A	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 2570H	FDA UDI	Class II	Unknown
UF(II) Internal Pick-up Impression Coping	IPI 60008N	FDA UDI	Class I	Active
UF(II) Eco H-Scan Body	USNHCD 4005H	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45104H	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 05 A01	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 7010S	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 2716N	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	SHN 2009	FDA UDI	Class II	Active

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