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 Implant System	PSWF 6512S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SASC 5808	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45207H(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCS 2720S	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALN 4570H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3313SF	FDA UDI	Class II	Active
DIO Megagen Pre-Milled Bar	CBME 02[H]	FDA UDI	Class I	Active
Secure Implant System(2.5/3.0mm)	MCB 3512	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 2008D<VerA>	FDA UDI	Class I	Active
UV Active Implant System	UF(II) 5508UV3	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHN 40503	FDA UDI	Class II	Unknown
DIO Screw Remove	SR 34	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAG 4810T	FDA UDI	Class II	Unknown
DIOnavi. Scan Retractor Upper jaw	SCANR 01	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45304H(II)	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AMN 50639N	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 3708B	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5214	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SHN 2009	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 50225	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 68GN	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4508UV3	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55107H(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45405H	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACN 3570H	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ESF 3316R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45405	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	PMN 40310	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DALR 5555H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40405N	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4507SF	FDA UDI	Class II	Active
DIO Reamer Pin	SRP 48	FDA UDI	Class I	Active
UF(II) Scan Adapter	SCAN 662H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHT 50605	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45105	FDA UDI	Class II	Active
DIO Screw Driver	HD 0920	FDA UDI	Class I	Active
UF Implant System	PSWF 7006S	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 25210	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSKA 4802	FDA UDI	Class II	Active
DIO STEADY External Implant System	ETF 3316R	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 4007S	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40707H	FDA UDI	Class II	Active
FTN Fixture Driver	HGC 3535	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7845T(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 3810S	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5513S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40619N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4824N(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48004EX	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75207N(II)	FDA UDI	Class II	Unknown

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