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
UniCon Abutment Impression Cap	DIO Implant System Product Catalog Ver 7.0 (KR)	EUDAMED	Class I	Active
UF(II) Internal Hybrid Link	DIO Implant System Product Catalog Ver 7.0 (KR)	EUDAMED	Class IIb	Active
UF(II) 2-Channel Abutment	DIO Implant System Product Catalog Ver 7.0 (KR)	EUDAMED	Class IIb	Active
UF(II) Hybrid Link	DIO Implant System Product Catalog Ver 7.0 (KR)	EUDAMED	Class IIb	Active
UniCon Abutment Protect Cap	DIO Implant System Product Catalog Ver 7.0 (KR)	EUDAMED	Class I	Active
DIOnavi. Initial Positioning Drill	DIO Implant System Product Catalog Ver 7.0 (KR)	EUDAMED	Class IIa	Active
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 4011S	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 3310R	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DLR 5570H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65305H(II)	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 05 A02(a,b)	FDA UDI	Class I	Active
UF(II) Internal Guide	INT 11N	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 09	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 00 A01(a,b)	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4845N(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RCN 40414	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 551515N	FDA UDI	Class II	Unknown
DIOnavi. Implant Connector	GWIC 6808ST	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 75107	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	SWF 7014S	FDA UDI	Class II	Unknown
DIOnavi. Abutment Profile Drill	UAPD 5823<VerA>	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6511S	FDA UDI	Class II	Active
UF Implant System	UF 4515S	FDA UDI	Class II	Unknown
UF(II) DA Protect Cap	DCMR 70	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 553015BH	FDA UDI	Class II	Active
UF(II) Implant System	SSHA 5520	FDA UDI	Class II	Unknown
DIO Screw Driver	HD 1710A	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4010N	FDA UDI	Class II	Active
UF(II) Internal Plastic Cylinder	API 60714[T]	FDA UDI	Class I	Active
DIO Straight Drill	DSU 4818M	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 5010SM	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3807DW<Al>	FDA UDI	Class I	Active
DIO Tap Adapter	TAPA 3011A	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45307N(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSAA 402015N	FDA UDI	Class II	Active
Pre-milled Bar	CBMC 02N	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHI 48602H	FDA UDI	Class II	Active
DIO Scan Adapter	SCAN 22-15[H]	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65405N(II)	FDA UDI	Class II	Active
Dio Protem Implant System	MFP 25408	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USPN 5504N	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAC 5816N	FDA UDI	Class II	Unknown
DIOnavi-SG	3DSG-1000	FDA UDI	Class I	Active
DIO Steady External Implant System	PETF 3316R	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAP 6510S	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USP 4804N	FDA UDI	Class II	Active
UCLA Plastic Abutment	APN 35413N[H]	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	SHT 2009S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40407H	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 25414	FDA UDI	Class II	Active

DIO Corporation

What DIO Corporation makes

Frequently asked questions

Information

Catalogue (5538)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities