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 Uf Hsa Internal Sub-Merged Implant System	SSSA 55254	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 3213D	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	SHN 2010	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 3811S	FDA UDI	Class II	Active
FTN Tapered Drill	DTH 3308SD	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 4855	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 5846N	FDA UDI	Class II	Unknown
DIO Screw Guide Tap	SGT 2518A	FDA UDI	Class I	Active
UF(II) Internal Count Sinker	CSUI 3620	FDA UDI	Class I	Active
DIO STEADY External Implant System	ESF 4513R	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFB 25208	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	IOTI 48010	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMT 50619N	FDA UDI	Class II	Unknown
DIO Parallel Pin	PP 1223	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5015S	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHT 50606	FDA UDI	Class II	Active
DIO Screw Driver	MD 1722	FDA UDI	Class I	Active
DIOnavi. Guide sleeve	GS 53BL	FDA UDI	Class I	Active
UF(II) Parallel Pin	SPP 2020	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4547	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6535	FDA UDI	Class II	Unknown
DIOnavi. Implant Connector	GIC 5312ST R	FDA UDI	Class I	Active
DIO Steady External Implant System	PESF 6010R	FDA UDI	Class II	Unknown
DIO Fixture Removing Driver	NFRD 11S	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4814T(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAP 4510B	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65205H(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40407N	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AAN 40415	FDA UDI	Class II	Unknown
DIOnavi. Guide Sleeve	GSC 68GN	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55305H(II)	FDA UDI	Class II	Unknown
DIO Round Drill	GSRD 3221	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AEI 48007	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 48115A	FDA UDI	Class II	Unknown
DIO Screw Driver	MD 1239L	FDA UDI	Class I	Active
DIO Straight Drill	DSU 2018M	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 45404	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DALR 2555N	FDA UDI	Class II	Unknown
FTN Scan Adapter Screw	ESSC 2510H	FDA UDI	Class I	Active
UF(II) Internal Pick-up Impression Coping	IPI 60012Y	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ABI 48350	FDA UDI	Class II	Active
UF(II) Multiunit Angled Abutment Jig	MAJ 02	FDA UDI	Class I	Active
DIO Remove Bar	RB 34	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 5016R	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 35440	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 02 A05(a,b)	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 4516SF	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48002G	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75354	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	MSD 2018D	FDA UDI	Class I	Active

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