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iTero Lumina Pro

by Align Technology Ltd. EUDAMEDGUDID

Active European Union

Ref 221959

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00816063022312 UDI-DIDate25 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number081606302LMNPRO88 Basic UDI-DIDate15 May 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
iTero Lumina Pro EUDAMED
iTero Lumina Pro DOA GUDID
Generic Name
Intraoral optical scanning system
Device Name
iTero Lumina™ Pro / iTero Lumina™ Pro Mobile
Model / Reference
221959
Primary DI / UDI-DI
00816063022312
Basic UDI-DI
081606302LMNPRO88
510(k) Number
FDA Product Code
NTK, QJK
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
GMDN Term
Intraoral optical scanning system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.1745, 872.3661
Medical Purpose
iTero Lumina Pro is dental imaging system intended to record and display the topographical images of teeth, oral tissue and bite relationship and to obtain optical impressions for use in CAD/CAM of dental devices. The system is also intended to record and display near infrared images of the teeth to aid in detecting interproximal caries above the gingiva and monitoring the progress of such lesions.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IL-PR-000047276

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No