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 2019N	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6844(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIP 3913T	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 6007SF	FDA UDI	Class II	Active
UFIII Fixture	UFIII 4507S	FDA UDI	Class II	Active
DIO Steady External Implant System	PETF 6011R	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 58325	FDA UDI	Class II	Unknown
DIOnavi. Tissue Punch	GTP 6623	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 4511SF	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3016	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 551525N	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	ACT 50612	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 554025BH	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 3944N	FDA UDI	Class II	Unknown
DIOnavi. Abutment Jig	AJ3D 05N	FDA UDI	Class I	Active
UF(II) DA Protect Cap	DACLR 55	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40705N	FDA UDI	Class II	Unknown
UF(II) Fixture	UF(II) 5505SF	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3011M	FDA UDI	Class I	Active
DIOnavi. Tap Drill	GTD 5515DW	FDA UDI	Class I	Active
UF(II) Eco H-Scan Body	USHCD 6505H	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5507S	FDA UDI	Class II	Unknown
UF(II) Pick-up Impression Coping	SSPI 4013H	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40605N	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 5008SF	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DLN 4555H	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DCR 4570N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 5555H	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAT 5810T	FDA UDI	Class II	Unknown
UCLA Plastic Abutment	APN 40513N[H]	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 6515H	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4535	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 55404	FDA UDI	Class II	Active
Dio Protem Implant System	MFP 25412	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 6013UV3	FDA UDI	Class II	Active
DIO Scan Adapter Screw	SSCAN 1612H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPT 5008	FDA UDI	Class I	Active
Wax Denture	WDL 03	FDA UDI	Class I	Active
DIO Implant Systems	PSI 4812P	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40542	FDA UDI	Class II	Unknown
Dio Sm Implant System	SSC 3106	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPN 3508	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	PMN 35315	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TCN 40511	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45257	FDA UDI	Class II	Unknown
UF(II) Eco Angled Post	USAP 550806AH	FDA UDI	Class II	Active
UF Implant System	UF(II) 4011S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 40225	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 4008PM	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMI 65435	FDA UDI	Class II	Unknown

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