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 Drill Stopper	ST 2011F	FDA UDI	Class I	Active
UF Implant System	PSWF 7014S	FDA UDI	Class II	Unknown
Protem Stopper	PST 04	FDA UDI	Class I	Active
DIO Screw Guide Tap	SGT 2018A	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 5508SF	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5824N(II)	FDA UDI	Class II	Unknown
UF(II) Bar holder abutment	MBHA 4509N	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SMA 6015N	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ETF 4016R	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SASA 4804	FDA UDI	Class II	Unknown
SM-Extra Wide Implant System	MX 6910	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 1540N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 6510N	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DLR 1555N	FDA UDI	Class II	Unknown
DIO Gerald Tweezer	MIT 06	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPI 48004NEX	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 6010R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3008SF	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45507N	FDA UDI	Class II	Active
UF(II) Implant System	UNSSA 40107	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 75504	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 3964N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6867(II)	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 08 A03	FDA UDI	Class I	Active
Cemented Abutment	AMI 48007N[H]	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SASC 4808	FDA UDI	Class II	Unknown
DIOnavi. Initial Drill	ISD 2005M<VerA>	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 45507	FDA UDI	Class II	Active
DIOnavi. Initial Drill	ISD 2010<VerA>	FDA UDI	Class I	Active
Dio Protem Implant System	MFP 25414	FDA UDI	Class II	Unknown
DIO Guide Sinus Approach Stopper	GST 12BL	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3810M	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 4515SF	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAH 6224	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75455	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 5510H	FDA UDI	Class II	Unknown
UF(II) Scan Adapter	SCAN 561H	FDA UDI	Class I	Active
DIO Steady External Implant System	ESF 4513R	FDA UDI	Class II	Unknown
Protem Straight Drill	MSD 2518	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	SWF 6514S	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 3715R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45507N	FDA UDI	Class II	Unknown
DIOnavi. Scan Retractor Lower jaw	SCANR 02	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 45207	FDA UDI	Class II	Active
DIO Sinus Round Drill	SRD 3008	FDA UDI	Class I	Active
UF(II) Internal Transfer Impression Coping	ITI 48010N	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSHA 4047	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 55307	FDA UDI	Class II	Unknown
FTN Fixture Mount	EMN 3508T[H]	FDA UDI	Class I	Active
Dio Implant Systems	ABN 40505	FDA UDI	Class II	Active

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