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) Scan Adapter	SCAN 642H	FDA UDI	Class I	Active
FTN Fixture Mount	EMT 5008[H]	FDA UDI	Class I	Active
DIO Dr. SOS+ Kit	DRS 02<VerC>	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 12 A02(a,b)	FDA UDI	Class I	Active
DIOnavi. Profile Drill	GNPD 3305DN	FDA UDI	Class I	Active
Wax Denture	WDU 02	FDA UDI	Class I	Active
DIOnavi. Guide	GUIDE02 01(a,b)	FDA UDI	Class I	Active
FTN Fixture Driver	HGC 5020	EUDAMEDFDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 07 A01	FDA UDI	Class I	Active
DIOnavi. Surgical Guide Fix Pin	SGFP 2008	FDA UDI	Class I	Active
DIO Straight Drill	DSU 5007	FDA UDI	Class I	Active
UF(II) Scan Adapter	SCAN 6101H	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4015S	FDA UDI	Class II	Active
DIO Solid Abutment Driver	HDS 4506A	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 5503H	FDA UDI	Class II	Active
DIO Screw Driver Ratchet Wrench (Nobel)	WHD 1715A	FDA UDI	Class I	Active
DIO Straight Drill	DSU 3011D	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3011	FDA UDI	Class I	Active
DIO Round Drill	GSRD 2821	FDA UDI	Class I	Active
UF(II) Internal Depth Gauge	DPI 2050	FDA UDI	Class I	Active
UF(II) Internal Transfer Impression Coping	ITI 60010Y	FDA UDI	Class I	Active
DIOnavi. Initial Drill	ISD 2015M<VerA>	FDA UDI	Class I	Active
FTN Pick-up Impression Coping	IPN 35412N	FDA UDI	Class I	Active
DIOnavi. Initial Drill	ISD 2011<VerA>	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USP 5505N	FDA UDI	Class II	Active
DIOnavi. Abutment Profile Drill	UAPD 5123<VerA>	FDA UDI	Class I	Active
UFIII Fixture	UFIII 3808S	FDA UDI	Class II	Active
UF(II) Eco Digital Coping Screw	USCSC 1604H	FDA UDI	Class I	Active
Protem Straight Drill	MSD 2012	FDA UDI	Class I	Active
DIOnavi. Tap Drill	GNTD 3315	FDA UDI	Class I	Active
Angled Abutment	AAN 40225[H]	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 01 A04	FDA UDI	Class I	Active
DIO Multi Screw Driver	MSD 1425	FDA UDI	Class I	Active
Protem Fixture Driver Assy	MGR 3520	FDA UDI	Class I	Active
DIO Straight Drill	DSU 4815M	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 08 A04	FDA UDI	Class I	Active
FTN H-Scan Body	EWHSB 661H	FDA UDI	Class I	Active
UF(II) Narrow DA Protect Cap	DCLN 70	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 5008DW	FDA UDI	Class I	Active
UF(II) Internal Guide	INT 5.7S	FDA UDI	Class I	Active
DIOnavi. Straight Drill	MSD 1218D	FDA UDI	Class I	Active
FTN Fixture Mount	EMW 51210[H]	FDA UDI	Class I	Active
DIO Straight Drill	DSU 4310D	FDA UDI	Class I	Active
UF(II) Narrow Plastic Coping	UNSAP 4010S	FDA UDI	Class I	Active
DIOnavi-P. MAX	3DCNBF-1000A0<VerA>	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 04H	FDA UDI	Class I	Active
DIOnavi. Anchor Drill	AD 2015	FDA UDI	Class I	Active
UF(II) Eco Transfer Impression Coping	USNTI 4010H	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USPN 5507N	FDA UDI	Class II	Active
UF(II) DA Protect Cap	DCPR 40	FDA UDI	Class I	Active

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