IRIS™, PEEK Comfort Cap, RH 4mm IR0181

by Adin Dental Implant Systems Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290109302348 UDI-DI	Date16 May 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: IRIS™, PEEK Comfort Cap, RH 4mm
Generic Name: Dental implant suprastructure, temporary, preformed, single-use
Model / Reference: IR0181

Primary DI / UDI-DI: 07290109302348
FDA Product Code: NDP
GMDN Term: Dental implant suprastructure, temporary, preformed, single-use

Device Class: Class I
Regulation Number: 872.3980
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Single Use
Implantable
Prescription Use
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (8)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No