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. Anchor Screw	ASC 1515S	FDA UDI	Class I	Active
UF(II) Impression Cap	SSAI 4511	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 3570N	FDA UDI	Class II	Unknown
UF(II) Internal Solid Abutment Analog	RMI 48007	FDA UDI	Class I	Active
Secure Implant System	MFP 30216A	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5016S	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 65257	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 554015AH	FDA UDI	Class II	Unknown
UF Implant System	UF(II) 5015S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SSC 1812	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48002Y	FDA UDI	Class I	Active
UF(II) Narrow Scan Adapter Screw	UNSCAN 1416H	FDA UDI	Class I	Active
DIO Implant System	IFI 4812M	FDA UDI	Class II	Unknown
DIO Guide Sinus Approach Stopper	GST 04YE	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 451515BH	FDA UDI	Class II	Active
Fixture Mount	EMR 4008	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSSA 40705	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55504H(II)	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACN 5555H	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFW 5310H	FDA UDI	Class II	Active
UF(II) Scan Adapter	SCAN 761H	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DLR 3555H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55107N(II)	FDA UDI	Class II	Unknown
UF Implant System	UF 5010S<VerA>	FDA UDI	Class II	Unknown
DIO Implant System	FTN 3310B	FDA UDI	Class II	Unknown
Fixture Mount	EMW 51210	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 4513SM	FDA UDI	Class I	Active
DIO Implant Systems	FSN 4010B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMI 48027	FDA UDI	Class II	Unknown
DIO Mount Driver	MHDR 2513A	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45307H(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4513SF	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHT 50603	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5838	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 1570N	FDA UDI	Class II	Unknown
DIOnavi. Initial Drill	ISD 2015<VerA>	FDA UDI	Class I	Active
DIOnavi-P. MAX	3DCNBF-1000A2<VerA>	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4311M	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	SWF 6512S	FDA UDI	Class II	Unknown
DIOnavi-C&B	3DCNB-1000A2	FDA UDI	Class I	Active
SM Implant System	SFN 3812	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFW 5314H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSAA 404015BH	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 4010UV3	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 553015AH	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 65309	FDA UDI	Class II	Active
UF(II) Eco Bite Impression Coping	USNBI 4204H	FDA UDI	Class I	Active
UF(II) Pick-up Impression Coping	SSPI 5509H	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 02 A04(a,b)	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUN 3570H	FDA UDI	Class II	Unknown

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