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
Sm Internal/External Implant Systems	AMN 50631	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 55204	FDA UDI	Class II	Unknown
DIO Guide Sinus Approach Stopper	LST 10RD	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAC 4826N	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 53GN	FDA UDI	Class I	Active
DIO Zimmer Scan Adapter	SCAN 08-15[T]	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SSG 1820	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSMUA 483020N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45307	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4020S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TMN 40512N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45407N(II)	FDA UDI	Class II	Unknown
DIOnavi. Guide Sleeve	GSC 53BL_10	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AAN 35415	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	CHN 4000N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 4835	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 6537	FDA UDI	Class II	Unknown
DIO Pilot Drill	PS 3512	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75254	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 5837(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAG 3910T	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TCN 40511N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45107H(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 50640	FDA UDI	Class II	Unknown
Dio Mit Kit	MITK 01	FDA UDI	Class I	Active
UF(II) Internal Fixture Driver	OFDW 4818A	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	HMI 48557EX	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ACT 50623	FDA UDI	Class II	Unknown
Hybrid Link	UNHL 40551H	FDA UDI	Class II	Active
UF Implant System	UF 4513S<VerA>	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 5007UV3	FDA UDI	Class II	Active
FTN Scan Adapter Screw	ESSC 2508H	FDA UDI	Class I	Active
UF Implant System	UF(II) 5516S	FDA UDI	Class II	Unknown
UF(II) Eco Pickup Impression Coping	USNPI 4206N	FDA UDI	Class I	Active
UF(II) Internal Pick-up Impression Coping Screw	IOTI 48010S	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40105H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 40307	FDA UDI	Class II	Unknown
DIO Implant Systems	FTN 3313B	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFB 20414	FDA UDI	Class II	Active
DIO STEADY External Implant System	ESF 5008R	FDA UDI	Class II	Unknown
Protem Sugical Kit	PRT(M) 00	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DALN 1555N	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ETF 3313R	FDA UDI	Class II	Unknown
UF(II) Bone Profile Drill	BPD 5608G	FDA UDI	Class I	Active
DIO Drill Stopper	ST 2007F	FDA UDI	Class I	Active
DIO Steady External Implant System	PESF 3710R	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 4844N	FDA UDI	Class II	Unknown
DIO Implant System	PSI 4014	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4020	FDA UDI	Class II	Unknown
UF(II) Pick-up Impression Coping	MPI 4811N	FDA UDI	Class I	Active

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