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 Steady External Implant System	PETF 6013R	FDA UDI	Class II	Unknown
UF(II) Eco Angled Post	USAP 480818AH	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 75405H(II)	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	HMI 48557EX	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAC 5826T	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPT 50612N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 1555N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	IPI 60710	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 55407	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3208	FDA UDI	Class I	Active
Protem Fixture Driver(Ratchet)	PPDH 3510	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 48588	FDA UDI	Class II	Unknown
DIO Sinus Elavator	DSNK 01	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45305N(II)	FDA UDI	Class II	Unknown
DIOnavi. Anchor Screw	ASC 1519S	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 65309N	FDA UDI	Class II	Active
Secure Implant System(2.5/3.0mm)	MAB 3014	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 48325B	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALR 3570N	FDA UDI	Class II	Unknown
DIOnavi. Abutment Jig	AJ3D 03	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSBA 3520	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 48508	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAC 3944T	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5011S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45307	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48002YEX	FDA UDI	Class II	Unknown
Dio Implant Systems	ABN 40504	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFW 5312H	FDA UDI	Class II	Active
DIOnavi. Anchor Sleeve	AS 20SET	FDA UDI	Class I	Active
DIO Steady External Implant System	ESF 4508R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 45405	FDA UDI	Class II	Unknown
DIO Internal Fixture Removing Driver	FRD 8S	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45304N(II)	FDA UDI	Class II	Active
UF(II) Wide	UF(II) 6510SF	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAS 4216	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75557	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 55554	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 65107	FDA UDI	Class II	Active
UF(II) Implant System	UNSSA 40405	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	PSWF 6014S	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 4515S	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5507S	FDA UDI	Class II	Unknown
DIOnavi. Abutment Profile Drill	UAPD 5124	FDA UDI	Class I	Active
DIO Straight Drill	DSU 4813M	FDA UDI	Class I	Active
UF(II) Fixture	UF(II) 4007UV3	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3010DN<TiN>	FDA UDI	Class I	Active
UF Implant System	UF(II) 5010S	FDA UDI	Class II	Unknown
DIO Screw Driver	MD 0930L	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	TMN 50612	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ACI 48302	FDA UDI	Class II	Unknown

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