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
DIOnavi. Guide Sleeve	GSL 36YE	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSMUA 482520N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40507H	FDA UDI	Class II	Active
DIO Removing Driver	HR 12L<VerA>	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7864N(II)	FDA UDI	Class II	Unknown
UF(II) Initial Drill	DHF 2015SM<VerA>	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 12 A02	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4307DW	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6845(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3313S	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 65557	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALR 1555H	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 5013S	FDA UDI	Class II	Active
UF(II) Narrow DA Protect Cap	DCUN 70	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	RMI 65004N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIP 5807T	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 3211D	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSMA 6530H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40620N	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 4008S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SMA 5515N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSBA 3570	FDA UDI	Class II	Active
DIO Screw Driver	MD 1719	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 75407	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5015S	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PSWF 6008S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75304N(II)	FDA UDI	Class II	Active
UF(II) Internal Tap Drill	UITD 5515	FDA UDI	Class I	Active
DIO Straight Drill	DSU 2711M	FDA UDI	Class I	Active
DIO Straight Drill	DSU 3808M	FDA UDI	Class I	Active
UF(II) Internal Tap Drill	UITD 5015	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ACN 40523	FDA UDI	Class II	Unknown
UF(II) Implant System	DASC 2008H	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55507H(II)	FDA UDI	Class II	Unknown
DIOnavi. Profile Drill	GPD 4505M	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6827(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SMA 4514T	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 3926T	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	RCI 60014	FDA UDI	Class I	Active
DIO Implant Systems	FTN 5511B	FDA UDI	Class II	Unknown
Secure Implant System	MFP 30414A	FDA UDI	Class II	Active
UF(II) Narrow Jig Cylinder	MJC 5409N	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DMR 3570N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMI 48027N	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 4815	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSMA 4520N	FDA UDI	Class II	Unknown
Dio Implant Systems	AAI 35025NA	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAC 3914N	FDA UDI	Class II	Unknown
Mill Abutment	UNSMA 4550H	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SIP 3910T	FDA UDI	Class II	Unknown

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