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iTero Lumina Pro intraoral scanning unit
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 221909Model iTero Lumina Pro intraoral scanning unit 510(k) K240573
Identity
- Trade Name
- iTero Lumina Pro intraoral scanning unit EUDAMED
- Device Name
- iTero Lumina Pro intraoral scanning unit EUDAMED
- Model / Reference
- iTero Lumina Pro intraoral scanning unit EUDAMED221909 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022190 EUDAMED
- Basic UDI-DI
- 081606302IOCPRO5A EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental implant suprastructure, temporary, preformed, single-use
iTero Lumina Pro intraoral scanning unit by Align Technology Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K240573 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081606302IOCPRO5A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Align Technology Ltd.
- EUDAMED SRN
- IL-MF-000000745
- FDA Applicant
- Align Technology , Ltd.
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (2)
- EUDAMED b521886b-232d-4a50-8e5d-ee07488beb18 85 fields · synced Jun 18, 2026
- FDA 510(k) K240573 1 fields · synced May 18, 2026