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	SIT 4813S	FDA UDI	Class II	Unknown
Pre-milled Bar	CBZN 01	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUR 5555N	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 45405	FDA UDI	Class II	Active
FTN Surgical Kit	FTN 01-M	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCN 5570N	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 25412	FDA UDI	Class II	Active
DIO Sinus Approach Stopper	ST 06BL	FDA UDI	Class II	Active
DIO Straight Drill	DSU 3010D	FDA UDI	Class I	Active
FTN Fixture Mount	EMN 3508[T]	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3008	FDA UDI	Class I	Active
Dio Implant Systems	ABN 40504	FDA UDI	Class II	Active
UF(II) Profile Drill	UPD 3805D	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DMR 4540N	FDA UDI	Class II	Unknown
FTN H-Scan Body	ERHSB 561H	FDA UDI	Class I	Active
DIO Solid Abutment Driver	HDS 5506A	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 6504	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUR 2570H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAI 35025	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 55307	FDA UDI	Class II	Active
DIOnavi. Marker	SGM 5040	FDA UDI	Class I	Active
Protem Fixture Driver Assy	MGR 3410A	FDA UDI	Class I	Active
DIO Implant Systems	PSI 4010P	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	AGI 60004	FDA UDI	Class II	Unknown
DIO Sinus Kit	DSNK 03	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSHA 4524	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DMR 2555N	FDA UDI	Class II	Unknown
FTN Scan Adapter	SCAN 04[H]	FDA UDI	Class I	Active
UF(II) Bar holder abutment	MBHCA 4507N	FDA UDI	Class II	Unknown
DIO Guide Sinus Approach Stopper	LST 20YE	FDA UDI	Class I	Active
DIOnavi. Guide Sleeve	GSC 68GN_10	FDA UDI	Class I	Active
UF Implant System	PUF(II) 4011S	FDA UDI	Class II	Unknown
DIO Screw Driver	MD 1234	FDA UDI	Class I	Active
DIO Implant System	IFI 4010M	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 3711R	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DCR 4555H	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 3316R	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPT 50612	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 5013UV3	FDA UDI	Class II	Active
DIO Scan Adapter Screw	SSCAN 1610H	FDA UDI	Class I	Active
UF Implant System	UF(II) 5507S	FDA UDI	Class II	Unknown
UF Implant System	PUF(II) 4515S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIP 5807N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 552015AH	FDA UDI	Class II	Unknown
DIOnavi. Initial Drill	ISD 2018N<VerA>	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SMA 6513N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUR 5570H	FDA UDI	Class II	Unknown
UF(II) Internal Count Sinker	CSUI 4020	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUR 1570N	FDA UDI	Class II	Unknown
DIOnavi. Tap Drill	GTD 4015	FDA UDI	Class I	Active

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