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(II) Narrow Implant System	UNSCA 45505N	FDA UDI	Class II	Unknown
Multi Angled Abutment	MAA 484530H	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45157	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 4812M	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALN 4555N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPN 50608N	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45105H	FDA UDI	Class II	Active
UF(II) Implant System	UNSSA 45204	FDA UDI	Class II	Unknown
DIO Megagen Pre-Milled Bar	CBMS 02[H]	FDA UDI	Class I	Active
SM Guide Pin	SSG 2329	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45404N(II)	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5508S	FDA UDI	Class II	Unknown
DIO Sinus Master Kit	SMK 01	FDA UDI	Class I	Active
DIO Implant Systems	PSI 4014	FDA UDI	Class II	Unknown
UF(II) Fixture	UF(II) 6005SF	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	RMN 40412	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45604H	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6865(II)	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 6010R	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAB 3904	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 4837(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RCN 40412	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2717DN	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SIP 4807N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AEI 48017N	FDA UDI	Class II	Unknown
Bone Expander	BEP 1731	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 4011S	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4016S	FDA UDI	Class II	Active
DIO Guide Drill	GD 1827M	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DALR 1570N	FDA UDI	Class II	Unknown
UF(II) Eco Base Abutment	USBA 4502N	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 75405N(II)	FDA UDI	Class II	Unknown
Secure Implant System(2.5/3.0mm)	MHC 5008	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 4010S	FDA UDI	Class I	Active
UF(II) Bar holder Abutment Clip Carrier	MBHCC 20	FDA UDI	Class I	Active
Extension Cemented Abutment	AEI 48027N[H]	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AGT 50614	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4015S	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 3315SD	FDA UDI	Class I	Active
DIO Straight Drill	DSU 2007M<VerA>	FDA UDI	Class I	Active
UF Implant System	PUF(II) 5010S	FDA UDI	Class II	Unknown
DIO Square Hex Screw Driver	SHD 1220	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	CHT 5001	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSMUA 485020N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPN 40510N	FDA UDI	Class II	Unknown
FTN Pre-Milled Bar	CBER 01[H]	FDA UDI	Class I	Active
UF(II) Pick-up Impression Coping	SSPI 4017N	FDA UDI	Class I	Active
UF(II) Eco Bite Impression Coping	USNBI 4004H	FDA UDI	Class I	Active
UF(II) Narrow Plastic Coping	UNSAP 4510B	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3807	FDA UDI	Class I	Active

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