IRIS™, WP Abutment, RH 4mm GH 2mm

FDA UDI

Class II (US FDA UDI)

by Adin Dental Implant Systems Ltd

Identity

Trade Name: IRIS™, WP Abutment, RH 4mm GH 2mm FDA UDI
Generic Name: Dental implant suprastructure kit FDA UDI
Model / Reference: IR0542 FDA UDI

Identifiers

Primary DI / UDI-DI: 07290109302751 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

Category: Dental implant suprastructure kit

IRIS™, WP Abutment, RH 4mm GH 2mm by Adin Dental Implant Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Adin Dental Implant Systems Ltd

Sources (1)

FDA UDI e1c12ece-dc9b-4c3c-af16-9911f28d841a 32 fields · synced May 30, 2026