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
Sm Internal/External Implant Systems	APN 35413	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40605N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 50425	FDA UDI	Class II	Active
FTN Fixture Mount	EMR 41210[H]	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65204N(II)	FDA UDI	Class II	Unknown
Dio Implant Systems	ABN 35505	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 2010D<VerA>	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75307N(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Fixture Driver Ratchet Wrench	UNFDW 3012	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45504N(II)	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALN 4555H	FDA UDI	Class II	Unknown
UF(II) Eastab Cylinder	ESMC 4812N	FDA UDI	Class II	Active
UF Implant System	PSWF 6006S	FDA UDI	Class II	Unknown
UF Implant System	PUF(II) 4015S	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 5513B	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 48315	FDA UDI	Class II	Unknown
Secure Implant System	MFB 30414A	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 40512S	FDA UDI	Class II	Unknown
Secure Implant System	MFB 30214A	FDA UDI	Class II	Active
DIOnavi. Trainer's Kit	DTK 01	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DMR 1570N	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4011SF	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 13 A03	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6513SF	FDA UDI	Class II	Active
DIO Osstem Pre-Milled Bar	CBOM 02[H]	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF 5007S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 5515N	FDA UDI	Class II	Active
DIOnavi. Implant Connector	GIC 5309	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DACR 5555N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	HMI 48554EX	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAP 5510S	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3811M	FDA UDI	Class I	Active
DIO Implant System	FTN 4013B	FDA UDI	Class II	Unknown
DIO Drill Stopper	ST 2013F	FDA UDI	Class I	Active
DIO Sinus Round Drill	SRD 3508	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 55207	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6834T(II)	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 20414	FDA UDI	Class II	Active
UF(II) Narrow Transfer Impression Coping Screw	UNSTI 4017S	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMI 48434EX	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 454025N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIP 4813T	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMI 48435EX	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 5865(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 3914T	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 3311R	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 73	FDA UDI	Class I	Active
DIO Steady External Implant System	ETF 6015R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75405	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45105N	FDA UDI	Class II	Unknown

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