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 Sm-Extra Wide(rbm) Implant Systems	SAC 5825T(II)	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 4513R	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 2015D<VerA>	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAA 58115B	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5834N(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 65104	FDA UDI	Class II	Active
UF(II) Eco Base Abutment	USBA 4804N	FDA UDI	Class II	Active
UF(II) Implant System	UCA 4801	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMI 48037	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMT 50620N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 555025N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45407N	FDA UDI	Class II	Active
Multi Angled Abutment	MAA 485530H	FDA UDI	Class II	Active
UF(II) Pick-up Impression Coping	SSPI 6519H	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65407H(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45205N	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2508DN	FDA UDI	Class I	Active
DIOnavi-SG02	3DCLRSG-1000	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 551515BH	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 4508R	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 3713R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 45204	FDA UDI	Class II	Unknown
DIOnavi. Implant Connector	GWIC 7308	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUR 2555H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSHA 4520	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 453025AH	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 09 A01	FDA UDI	Class I	Active
Angled Abutment	AAT 50225[H]	FDA UDI	Class II	Active
FTN Tapered Drill	DTH 4515S	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 4015S	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40705H	FDA UDI	Class II	Unknown
Multi Angled Abutment	MAA 483520H	FDA UDI	Class II	Active
DIO Straight Drill	DSU 5407M	FDA UDI	Class I	Active
DIO Implant Systems	FST 5011B	FDA UDI	Class II	Unknown
Dio Implant Systems	AAI 35025NB	FDA UDI	Class II	Active
DIOnavi. Guide Sleeve	GS 36YE_10	FDA UDI	Class I	Active
UF Implant System	PSWF 6514S	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 5815(II)	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 3308S	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USPN 4505N	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 452015N	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 5016SF	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	APT 50613	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65105H(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 40415	FDA UDI	Class II	Active
DIO Sinus Elavator	DSNK 05	FDA UDI	Class I	Active
Protem Stopper Holder(4mm)	PST 02	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AGI 48504	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 50612H	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 6015B	FDA UDI	Class II	Unknown

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