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) Tap Drill	UT(II) 6006	FDA UDI	Class I	Active
UF(II) Eco Angled Post	USAP 450806BH	FDA UDI	Class II	Active
UF(II) Narrow Transfer Impression Coping	UNSTI 4015H	FDA UDI	Class I	Active
DIO Fixture Driver(Machine)	FDC 3506	FDA UDI	Class I	Active
UF(II) Starter Kit	UFST 00	FDA UDI	Class I	Active
DIO Remove Bar	RB 32	FDA UDI	Class I	Active
Protem Fixture Driver Assy	MGR 3410	FDA UDI	Class I	Active
DIOnavi. Guide Drill	UGD 2005N<VERA>	FDA UDI	Class I	Active
UF(II) Healing Cap	MHC 5005	FDA UDI	Class I	Active
UF(II) Eastab Cylinder	ESMC 4812H	FDA UDI	Class II	Active
DIOnavi-P. MAX	3DCNBF-1000A1<VerA>	FDA UDI	Class I	Active
Protem Fixture Driver Assy	MGR 3415A	FDA UDI	Class I	Active
UFIII Fixture	UFIII 3808UV3	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3018	FDA UDI	Class I	Active
UF(II) Narrow Fixture Driver Contra Angle	UNFDC 3012	FDA UDI	Class I	Active
UF(II) Narrow Guide pin	MGP 1610	FDA UDI	Class I	Active
FTN Pick-up Impression Coping	IPN 35412	FDA UDI	Class I	Active
DIO Scan Adapter Screw	SSC 2508H	FDA UDI	Class I	Active
UFIII Fixture	UFIII 5010S	FDA UDI	Class II	Active
UF(II) Impression Cap	SSAI 6511	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 07	FDA UDI	Class I	Active
DIO Ball Abutment Holder	BAH 3520	FDA UDI	Class I	Active
UF(II) Internal H-Scan Body	IHSB 561	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 4501H	FDA UDI	Class II	Active
FTN Tapered Drill	DTH 5015SM	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 03 A02(a,b)	FDA UDI	Class I	Active
FTN Fixture Mount Screw	STN 1607H	FDA UDI	Class I	Active
DIO Straight Drill	DSU 3218M	FDA UDI	Class I	Active
Fixture Mount	EMR 4008T	FDA UDI	Class I	Active
DIO Screw Driver	HD 0515A	FDA UDI	Class I	Active
UF(II) Tap Drill	UT(II) 5015	FDA UDI	Class I	Active
DIO Straight Drill	DSU 5008	FDA UDI	Class I	Active
UF(II) Narrow Surgical Kit	UF 08	FDA UDI	Class I	Active
DIOnavi. Guide	GUIDE02 08(a,b)	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 11 A03	FDA UDI	Class I	Active
DIO Master Kit	UF 05<VerO>	FDA UDI	Class I	Active
UF(II) Narrow Tap Drill	UNTD 3015	FDA UDI	Class I	Active
UF(II) DA Protect Cap	DACLR 70	FDA UDI	Class I	Active
DIO Straight Drill	DSU 2713D	FDA UDI	Class I	Active
UF(II) Internal Transfer Impression Coping	ITI 48010Y	FDA UDI	Class I	Active
DIO Screw Driver	MD 1239	FDA UDI	Class I	Active
UF(II) Abutment Analog	MLA 4815H	FDA UDI	Class I	Active
DIO Starter Drill	SD 1533M	FDA UDI	Class I	Active
DIOnavi. Initial Drill	ISD 2011N<VerA>	FDA UDI	Class I	Active
UF(II) Internal Pre-Milled Bar	CBSI 02[H]	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4011UV3	FDA UDI	Class II	Active
FTN Tapered Drill	DTH 5011SM	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 2511DN	FDA UDI	Class I	Active
UF(II) Eco H-Scan Body	USHCD 6504H	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 03 A04	FDA UDI	Class I	Active

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