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 Biotite-H Implant Systems	SIP 4813N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5836	FDA UDI	Class II	Unknown
UF(II) Pick-up Impression Coping	SSPI 5513N	FDA UDI	Class I	Active
UF Implant System	UF 4013S	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 12 A04(a,b)	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF 5015S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 40512S	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65507H(II)	FDA UDI	Class II	Active
DIO Zimmer Scan Adapter	SCAN 09[H]	FDA UDI	Class I	Active
Cemented Abutment	AMI 48017N[H]	FDA UDI	Class II	Active
DIO Straight Drill	DSU 2010M	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75105N(II)	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AMI 48354	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40631N	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 36YE_50	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ABN 40502	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3313SF	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 3313SM	FDA UDI	Class I	Active
DIO Sinus Elavator	DSNK 06	FDA UDI	Class I	Active
DIOnavi. Anchor Screw	ASC 1515	FDA UDI	Class I	Active
Dio Sm Implant System	SAHN 5236	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 40407	FDA UDI	Class II	Unknown
DIOnavi. Initial Drill	ISD 2010M<VerA>	FDA UDI	Class I	Active
DIO O-Ring	OR 0450O	FDA UDI	Class I	Active
DIO Scan Adapter Screw	SSCAN 1614H	FDA UDI	Class I	Active
DIOnavi-C&B	3DCNB-1000A1	FDA UDI	Class I	Active
DIO Steady External Implant System	ESF 5016R	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 06 A04	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6010S	FDA UDI	Class II	Active
DIO Implant System	PSI 3510P	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 5015S	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 09 A01(a,b)	FDA UDI	Class I	Active
DIO Conical Abutment Driver	HD 2712A	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3813M	FDA UDI	Class I	Active
DIOnavi. Stopper	GST 2050RD	FDA UDI	Class I	Active
UF(II) Implant System	MSA 4804	FDA UDI	Class II	Active
DIO Steady External Implant System	PESF 6013R	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 4015R	FDA UDI	Class II	Unknown
DIOnavi-Cast	3DCAST-1000	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPI 48002GEX	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 4505N	FDA UDI	Class II	Active
UF Implant System	UF(II) 4513S	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5010S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 555015N	FDA UDI	Class II	Unknown
DIO Master Kit	UF 05<VerP>	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	CHN 4000N	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACN 4570N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 5866N	FDA UDI	Class II	Unknown
DIOnavi. Guide Drill	UGD 2005RM<VERA>	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 12	FDA UDI	Class I	Active

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