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
FTN Depth Gauge	DPE 2050	FDA UDI	Class I	Active
Secure Implant System	MFP 30214A	FDA UDI	Class II	Active
Fixture (HSA)	UF 3807S	FDA UDI	Class II	Unknown
DIOnavi-P. MAX	3DCNBF-1000B1<VerA>	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DLR 3555N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIP 3913N	FDA UDI	Class II	Unknown
DIO Implant System	PSI 4014P	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 4010SD	FDA UDI	Class I	Active
DIO Starter Drill	SD 1530M	FDA UDI	Class I	Active
DIO Biotite-H Implant System	SFR 4514H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 65254	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 39325B	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75407H(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45305	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACN 5570H	FDA UDI	Class II	Unknown
UF Implant System	UF 4016S	FDA UDI	Class II	Unknown
FTN Scan Adapter	SCAN 06[H]	FDA UDI	Class I	Active
UF Implant System	PSWF 6506S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45305N(II)	FDA UDI	Class II	Active
FTN Guide Pin	PMN 35320	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	PCN 40308	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	PMN 40315	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 5511	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 7867(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHI 65704H	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 6511S	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 5515B	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 4540H	FDA UDI	Class II	Unknown
DIO Strauman Scan Adapter	SCAN 13[H]	FDA UDI	Class I	Active
UF(II) Starter Kit	UFST 01<VerA>	FDA UDI	Class I	Active
Abutment Screw	SSC 2008SH	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DCN 4555H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75304H(II)	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	CHN 3501	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DCR 5555N	FDA UDI	Class II	Unknown
UF(II) Narrow Pre-Milled Bar	CBUN 01N	FDA UDI	Class I	Active
UF Implant System	UF(II) 4010S	FDA UDI	Class II	Unknown
CCM Cylinder	MCCM 5005N	FDA UDI	Class II	Unknown
UF Implant System	UF(II) 4515S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	APN 40514SN	FDA UDI	Class II	Active
DIO Implant Systems	IFI 4014PM	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SSC 1808H	FDA UDI	Class II	Unknown
DIO Implant Systems	FTN 3308B	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5510S	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALN 2555N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 4825	FDA UDI	Class II	Active
UF(II) Scan Adapter	SCAN 641H	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6515	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 06 A05(a,b)	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUN 1570H	FDA UDI	Class II	Unknown

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