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
UF(II) Anatomic abutment	DALN 1570N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	PMN 50315	FDA UDI	Class I	Active
UF(II) Narrow Surgical Kit	UF 14<VerC>	FDA UDI	Class I	Active
UF Implant System	UF 5016S	FDA UDI	Class II	Unknown
DIOnavi. Bone Flattening Drill	UBFD 3430	FDA UDI	Class I	Active
UF(II) Internal Count Sinker	CSUI 5520	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DACR 2570N	FDA UDI	Class II	Unknown
DIO Sinus Approach Lateral Round Drill	SLRD 5504	FDA UDI	Class I	Active
Mill Abutment	UNSMA 4050N	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAA 48125A	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6025	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45704H	FDA UDI	Class II	Unknown
DIO Scan Adapter	SCAN 15-15[H]	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 5507	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7824T(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSAA 404015N	FDA UDI	Class II	Active
UF(II) Pick-up Impression Coping	SSPI 4517H	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAH 6238	FDA UDI	Class II	Unknown
DIO Scan Adapter	SCAN 15[H]	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSSA 40604	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DLN 2555H	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 40705	FDA UDI	Class II	Active
UF(II) Eco Transfer Impression Coping	USTI 4810N	FDA UDI	Class I	Active
DIOnavi. Guide Sleeve	GSC 68GN_50	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45304N	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 03 A05(a,b)	FDA UDI	Class I	Active
DIO Implant System	PSI 4808P	FDA UDI	Class II	Unknown
UF(II) Parallel Pin	SPP 2025	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCN 1570N	FDA UDI	Class II	Unknown
UF(II) Pick-up Impression Coping	SSPI 5517N	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUN 4570H	FDA UDI	Class II	Unknown
UF(II) Narrow Impression Cap	UNSAI 4011	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUN 2570H	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFN 3808H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHN 40602	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 5011R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65205N(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 3810SF	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5835N(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45104	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUN 5570H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 65504	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 452015AH	FDA UDI	Class II	Active
DIO Guide Sinus Approach Stopper	GST 09BL	FDA UDI	Class I	Active
Secure Implant System	MFP 30212A	FDA UDI	Class II	Active
DIO Solid Abutment Driver	HD 4306A	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4307M	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 4015R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCS 2710	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 48325	FDA UDI	Class II	Unknown

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