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. Initial Drill	ISD 2008N<VerA>	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 08 A02(a,b)	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4007UV3	FDA UDI	Class II	Active
UF(II) Eco Base Abutment	USBA 6504N	FDA UDI	Class II	Active
DIOnavi. Implant Connector	GIC 5317	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 09 A02(a,b)	FDA UDI	Class I	Active
UF(II) Eco Angled Post	USAP 480812AH	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 13	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3215	FDA UDI	Class I	Active
FTN Fixture Mount	EMW 5008T[T]	FDA UDI	Class I	Active
FTN Surgical Kit	FTN(M) 01-M	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 4501N	FDA UDI	Class II	Active
FTN Fixture Mount	EMT 5008[T]	FDA UDI	Class I	Active
DIO Straight Drill	DSU 2010D	EUDAMEDFDA UDI	Class I	Active
DIO Reamer Pin	SRP 39	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 01 A03	FDA UDI	Class I	Active
DIOnavi. Guide sleeve	GS 73GN	FDA UDI	Class I	Active
UF(II) Pre-Milled Bar	CBSS 01N[H]	FDA UDI	Class I	Active
DIOnavi. Guide Drill	UGD 2005W<VerA>	FDA UDI	Class I	Active
UF(II) Scan Adapter	SCAN 01-15[H]	FDA UDI	Class I	Active
UF(II) Starter Kit	UFST 01	FDA UDI	Class I	Active
UF(II) Internal H-Scan Body	ITHSB 641	FDA UDI	Class I	Active
UF(II) Narrow Protect Cap	UNSAC 4507	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 2711M	FDA UDI	Class I	Active
UF(II) Narrow Transfer Impression Coping Screw	UNSTI 4015S	FDA UDI	Class I	Active
DIOnavi. Anchor sleeve	ASC 20	FDA UDI	Class I	Active
UF(II) Internal Fixture Driver	OFDC 4812	FDA UDI	Class I	Active
DIO Strauman Pre-Milled Bar	CBITR 02[H]	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4516S	FDA UDI	Class II	Active
DIO Straight Drill	DSU 2715M	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USPN 6505N	FDA UDI	Class II	Active
DIOnavi. Profile Drill	GPD 6005	FDA UDI	Class I	Active
DIO Straight Drill	DSU 5513	FDA UDI	Class I	Active
UF(II) Internal Fixture Mount	ITI 60014Y[H]	FDA UDI	Class I	Active
FTN Fixture Mount	EMR 4008[H]	FDA UDI	Class I	Active
UF(II) Pick-up Impression Coping	SSPI 4513N	FDA UDI	Class I	Active
DIO Screw Driver	HD 1215A	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4318	FDA UDI	Class I	Active
DIOnavi. Implant Connector	GIC 5309ST<VERC>	FDA UDI	Class I	Active
UF(II) Internal Pick-up Impression Coping	IPI 48012Y	FDA UDI	Class I	Active
UF(II) Narrow DA Protect Cap	DCUN 55	FDA UDI	Class I	Active
UFIII Fixture	UFIII 5011S	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 07 A02	FDA UDI	Class I	Active
DIO Water Membrane Lifter Tube	WML 6627-2	FDA UDI	Class I	Active
SM Pick-up Impression Coping	SIP 4813T	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4507UV3	FDA UDI	Class II	Active
DIO Screw Driver	MD 1722L	FDA UDI	Class I	Active
UF(II) Eco Angled Post	USAP 480806BH	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 13 A01	FDA UDI	Class I	Active
DIO Sinus Elavator	DSNK 02	FDA UDI	Class I	Active

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