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 Straight Drill	DSU 4313D	FDA UDI	Class I	Active
DIOnavi. Surgical Guide Fix Pin	SGFP 2005	FDA UDI	Class I	Active
DIO Water Membrane Lifter	WML 6627-2<VerA>	FDA UDI	Class I	Active
Reverse Tweezer	MIT 05	FDA UDI	Class I	Active
UF(II) Bar Holder Abutment Clip	MBHC 1525	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 5007DW	FDA UDI	Class I	Active
DIO Zimmer Scan Adapter	SCAN 09-15[T]	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 06 A04(a,b)	FDA UDI	Class I	Active
DIOnavi Guide	GUIDE 02 A05(a,b)	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3216	FDA UDI	Class I	Active
UF(II) Narrow DA Protect Cap	DCLN 70G	FDA UDI	Class I	Active
DIO Fixture Analog	NFA 3512	FDA UDI	Class I	Active
DIO Removing Driver	HR 12S<VerA>	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 03 A01(a,b)	FDA UDI	Class I	Active
UF(II) Narrow Impression Cap	UNSAI 4511	FDA UDI	Class I	Active
FTN Fixture Mount	EMW 5008[T]	FDA UDI	Class I	Active
DIOnavi. Guide sleeve	GS 53YE	FDA UDI	Class I	Active
DIOnavi. Surgical Guide Fix Pin	SGFP 2010	FDA UDI	Class I	Active
DIOnavi. Implant Connector	GNIC 5317	FDA UDI	Class I	Active
UF H-Scan Body Screw	MHSBSC 1603	FDA UDI	Class I	Active
UF(II) Scan Adapter	SCAN 661H	FDA UDI	Class I	Active
DIO Zimmer Scan Adapter	SCAN 09[T]	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 06H	FDA UDI	Class I	Active
UF(II) Internal Master Kit	UF 12	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 4504N	FDA UDI	Class II	Active
UF(II) Eco Pickup Impression Coping	USPI 5506N	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 10 A01	FDA UDI	Class I	Active
DIOnavi Guide	GUIDE 02 A02(a,b)	FDA UDI	Class I	Active
Angled Abutment	AAN 50225[H]	FDA UDI	Class II	Active
DIO Straight Drill	DSU 2013D<VerA>	FDA UDI	Class I	Active
DIO Parallel Pin	PP 2023	FDA UDI	Class I	Active
DIO Straight Drill	DSU 3215D	FDA UDI	Class I	Active
DIOnavi. Guide Sleeve	GSCS 36YE_10	FDA UDI	Class I	Active
UF(II) Eastab Cylinder Semi Final	ESMCSF 4806N	FDA UDI	Class II	Active
FTN Scan Adapter Screw	ESSC 1606H	FDA UDI	Class I	Active
UF(II) Pick-up Impression Coping	SSPI 6509H	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 4503H	FDA UDI	Class II	Active
FTN Tapered Drill	DTH 3310SD	FDA UDI	Class I	Active
Angled Abutment	AAT 50415[H]	FDA UDI	Class II	Active
Protem Fixture Driver	MGC 3420	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 2708DN	FDA UDI	Class I	Active
UF(II) H-Scan Body Jig	JIG 501	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USP 5504N	FDA UDI	Class II	Active
DIOnavi. Implant Connector	GICC 5309<VERC>	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4808DW	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 2716	FDA UDI	Class I	Active
DIO Drill Stopper	ST 6504	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4008UV3	FDA UDI	Class II	Active
DIO Scan Adapter	SCAN 18[H]	FDA UDI	Class I	Active
DIOnavi. Connector Extension	CE 6508M	FDA UDI	Class I	Active

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