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 UF HSA Internal Sub-Merged Implant System	UF(II) 5516S	FDA UDI	Class II	Active
DIO Implant Systems	FSN 3313B	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 4504	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 40407	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45207H	FDA UDI	Class II	Unknown
DIOnavi. Metal Needle Tip Long	MNTL	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 10 A02(a,b)	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMI 48007N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPN 50612	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AAI 35025	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4018S	FDA UDI	Class II	Unknown
Secure Implant System	MFP 30410A	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 6513S	FDA UDI	Class II	Active
UF(II) Pick-up Impression Coping	SSPI 4019H	FDA UDI	Class I	Active
Dio Protem Implant System	MFB 20212	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RMI 48007N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75104N(II)	FDA UDI	Class II	Active
UF(II) Pick-up Impression Coping	SSPI 4009N	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4507S	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAH 5238	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 4845	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 45605	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DCR 2555N	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 11 A03(a,b)	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSBA 3550	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSSA 40104	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMI 48357	FDA UDI	Class II	Unknown
DIO Sinus Approach Stopper	ST 11RD	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USP 4807N	FDA UDI	Class II	Active
FTN Fixture Driver	HGC 4030	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6008S	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSHA 4524	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 04 A04	FDA UDI	Class I	Active
UF(II) Eco H-Scan Body	USHCD 5504H	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 4008SF	FDA UDI	Class II	Active
UF(II) Trephine Drill	TRD 5749	FDA UDI	Class I	Active
Dio Protem Implant System	MFP 20212	FDA UDI	Class II	Unknown
UF(II) Eco Angled Post	USAP 550818AH	FDA UDI	Class II	Active
Secure Implant System(2.5/3.0mm)	MCB 3512	FDA UDI	Class II	Active
UF(II) Tap Drill	UT(II) 4515	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 02 A03	FDA UDI	Class I	Active
DIO Implant Systems	PSI 4810	FDA UDI	Class II	Unknown
UF(II) Profile Drill	UPD 4005M	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75105H(II)	FDA UDI	Class II	Active
FTN Scan Adapter	SCAN 21[H]	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6045	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SHN 2003	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 6007UV3	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAH 6213	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSCS 3400	FDA UDI	Class II	Active

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