ioConnect Kit IOK-DS

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref IOK-DSRef IOK-ZM

by TruAbutment Inc.

Identity

Trade Name: ioConnect Kit EUDAMEDFDA UDI
Generic Name: Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Device Name: ioConnect Kit EUDAMED
Model / Reference: IOK-DS EUDAMED
IOK-ZM EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 08800076470576 EUDAMED
08800076466753 EUDAMEDFDA UDI
Basic UDI-DI: 88000764ICKX3 EUDAMED
FDA Product Code: NDP FDA UDI
EMDN Code: P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term: Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.3980 FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

The ioConnect Kit is a reusable intraoral scanning accessory designed to enhance the accuracy of full-arch digital impressions for dental implant restorations. Classified under nomenclature code P01020180, it is intended for use with intraoral scanners to facilitate seamless data capture and eliminate stitching errors during the scanning process.

This kit is supplied as a reusable device and is not sterile or implantable. It is compatible with various intraoral scanners and is regulated under FDA 510K and MDR authorizations. The kit includes reference code IOK-DS and is assigned a UDI (88000764ICKX3) for traceability. Storage and reprocessing instructions are manufacturer-specific, as it is intended for multiple uses in clinical settings.

Frequently asked questions

What is the purpose of the ioConnect Kit?

The ioConnect Kit is a reusable intraoral scanning accessory designed to enhance the accuracy of full-arch digital impressions for dental implant restorations. It helps eliminate stitching errors during the scanning process when used with intraoral scanners.

Is the ioConnect Kit sterile or implantable?

The ioConnect Kit is not sterile or implantable. It is supplied as a reusable device intended for multiple uses in clinical settings, with storage and reprocessing instructions provided by the manufacturer.

What regulatory authorizations apply to the ioConnect Kit?

The ioConnect Kit is regulated under FDA 510K and MDR authorizations. It is classified under nomenclature code P01020180 and is a Class I device with risk class ID -203.

What is included in the ioConnect Kit and how is it identified?

The ioConnect Kit includes reference code IOK-DS and is assigned a UDI (88000764ICKX3) for traceability. It is compatible with various intraoral scanners to facilitate seamless data capture during dental implant restoration procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ioConnect™ - TruAbutment Inc., ioConnect™ compatible with URIS - TruAbutment Inc., TruAbutment ioConnect Kit - 3Shape

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K191913	Class I	Active
FDA 510(k)	United States	FDA_510K	K170259	Class I	Active
FDA 510(k)	United States	FDA_510K	K183106	Class I	Active
FDA 510(k)	United States	FDA_510K	K172304	Class I	Active
FDA 510(k)	United States	FDA_510K	K152559	Class I	Active
EUDAMED	European Union	CE/MDR	88000764ICKX3	Class I	Active

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Manufacturer

Manufacturer: TruAbutment Inc.
EUDAMED SRN: US-MF-000043448
Authorised Representative: AeMi World e.K DE-AR-000007704

Sources (4)

EUDAMED b469f02e-df56-44a6-a8e1-a54f0ffda0b8 61 fields · synced Sep 18, 2026
EUDAMED fdbf00fa-404c-4608-910a-3b79344a786d 61 fields · synced May 18, 2026
FDA UDI 6ebb93e3-d096-4b04-aeed-4bd7ac5cb4c5 32 fields · synced May 30, 2026
FDA 510(k) K191913 1 fields · synced May 18, 2026