ARi ExCon Implant System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K231967Ref ARIE324074MRef ARIE324076MRef ARIE323590MRef ARIE323556MRef ARIE323576MRef ARIE324556MRef ARIE324056MRef ARIE323550MRef ARIE323574MRef ARIE324070MRef ARIE324072MRef ARIE324594MRef ARIE324550MRef ARIE323596MRef ARIE324598MRef ARIE323594MRef ARIE324572MRef ARIE323592MRef ARIE324576MRef ARIE324558MRef ARIE324592MRef ARIE324092MRef ARIE324090MRef ARIE323558MRef ARIE324590MRef ARIE323578MRef ARIE323570MRef ARIE323598M

by Megagen Implant Co., Ltd.

Identity

Trade Name: ARi ExCon Implant FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: ARi ExCon Implant EUDAMED
Model / Reference: ARIE324074M EUDAMED
ARIE324076M EUDAMED
ARIE323590M EUDAMED
ARIE323556M EUDAMED
ARIE323576M EUDAMED
ARIE324556M EUDAMED
ARIE324056M EUDAMED
ARIE323550M EUDAMED
ARIE323574M EUDAMED
ARIE324070M EUDAMED
ARIE324072M EUDAMED
ARIE324594M EUDAMED
ARIE324550M EUDAMED
ARIE323596M EUDAMED
ARIE324598M EUDAMED
ARIE323594M EUDAMED
ARIE324572M EUDAMED
ARIE323592M EUDAMED
ARIE324576M EUDAMED
ARIE324558M EUDAMED
ARIE324592M EUDAMED
ARIE324092M EUDAMED
ARIE324090M EUDAMED
ARIE323558M EUDAMED
ARIE324590M EUDAMED
ARIE323578M EUDAMED
ARIE323570M EUDAMED
ARIE323598M EUDAMED
ARIE323594 FDA UDI
ARIE324076 FDA UDI
ARIE323576 FDA UDI
ARIE324594 FDA UDI
ARIE324074 FDA UDI
ARIE323596 FDA UDI
ARIE323574 FDA UDI
ARIE324576 FDA UDI

Identifiers

Catalog Number: ARIE323594M FDA UDI
ARIE324076M FDA UDI
ARIE323576M FDA UDI
ARIE324594M FDA UDI
ARIE324074M FDA UDI
ARIE323596M FDA UDI
ARIE323574M FDA UDI
ARIE324576M FDA UDI
Primary DI / UDI-DI: 08809931182425 EUDAMEDFDA UDI
08809854028725 EUDAMEDFDA UDI
08809931182388 EUDAMEDFDA UDI
08809854028855 EUDAMEDFDA UDI
08809854028718 EUDAMEDFDA UDI
08809931182432 EUDAMEDFDA UDI
08809931182371 EUDAMEDFDA UDI
08809854028817 EUDAMEDFDA UDI
08800292993828 EUDAMED
08809931182333 EUDAMED
08809931181121 EUDAMED
08809931181084 EUDAMED
08809931182357 EUDAMED
08809854028749 EUDAMED
08809854028701 EUDAMED
08809931181145 EUDAMED
08809854028879 EUDAMED
08809854028794 EUDAMED
08809931182418 EUDAMED
08809931181138 EUDAMED
08809854028848 EUDAMED
08809854028756 EUDAMED
08800292993835 EUDAMED
08809931182340 EUDAMED
08800292993842 EUDAMED
08809931182395 EUDAMED
08809931182401 EUDAMED
08809931182449 EUDAMED
Basic UDI-DI: 880972899218Q9 EUDAMED
510(k) Number: K231967 FDA 510(k)FDA UDI
FDA Product Code: DZE FDA 510(k)FDA UDI
EMDN Code: P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 872.3640 FDA 510(k)
Regulation Number: 872.3640 FDA 510(k)FDA UDI
Market of Registration: Netherlands EUDAMED
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

The ARi ExCon Implant System is a dental implant device designed for osseointegrated fixation in the jawbone. It features an external connection mechanism for prosthetic attachment, enabling secure restoration of single-tooth or multi-tooth dental replacements. The system is classified under dental implant categories, providing a stable foundation for abutment and crown placement.

This system is supplied sterile and intended for single-use, adhering to dental implant protocols. It is approved under FDA 510K and MDR regulations, with a Traditional 510(k) clearance via the Dental (DE) Advisory Committee. The device is packaged in sterile conditions and requires surgical placement by trained professionals in clinical settings, with no MRI safety restrictions specified.

Frequently asked questions

What types of dental restorations can the ARi ExCon Implant System support, and how does its external connection mechanism work?

The ARi ExCon Implant System is designed to support both single-tooth and multi-tooth dental replacements by providing a stable foundation for prosthetic attachments. Its external connection mechanism allows for secure fixation of abutments and crowns, ensuring long-term stability for osseointegrated implants in the jawbone. This design simplifies the attachment process for trained dental professionals during restoration procedures.

Is the ARi ExCon Implant System reusable, or is it intended for single-use only? How does this affect its clinical use?

The ARi ExCon Implant System is explicitly intended for single-use only, adhering to standard dental implant protocols. This ensures sterility and reduces the risk of cross-contamination, which is critical in surgical settings. Since it is supplied sterile and must be discarded after one use, clinicians must order replacements for each patient procedure, maintaining compliance with infection control standards.

What storage conditions should be followed for the ARi ExCon Implant System to preserve its sterility and functionality?

While the exact storage instructions aren’t detailed in the provided data, the system is packaged sterile and must remain unopened until use. Standard sterile storage practices—such as keeping it in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture—should be followed. Once opened, the system should be used immediately in a controlled surgical setting to avoid contamination.

How was the ARi ExCon Implant System evaluated for regulatory approval, and which advisory committee was involved?

The ARi ExCon Implant System received FDA 510K clearance through a Traditional 510(k) review process, determined to be *substantially equivalent* to a predicate device. The Dental (DE) Advisory Committee was involved in its evaluation, as indicated by the product code (DZE) and the advisory committee designation. This route ensures the device meets U.S. safety and performance standards for dental implants before clinical use.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K231967	Class II	Active

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Manufacturer

Manufacturer: Megagen Implant Co., Ltd.

Sources (37)

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