Identity
- Trade Name
- iTero Lumina Pro Upgrade FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- iTero Lumina Pro US Cart upgrade from Element Plus FDA UDI
- Model / Reference
- 221946 FDA UDI
- Description
- iTero Lumina Pro US Cart upgrade from Element Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063022428 FDA UDI
- 510(k) Number
- K240573 FDA UDI
- FDA Product Code
- NTK FDA UDIQJK FDA UDI
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1745 FDA UDI872.3661 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intraoral optical scanning system
iTero Lumina Pro Upgrade by Align Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intraoral optical scanning system.
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- COMFORT+ — D.D.S., Inc. · Class II
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Cleared under the same submission
K240573 also covers:
- iTero Lumina Pro — Align Technology, Inc.
- iTero Lumina Pro — Align Technology, Inc.
- iTero Lumina Pro — Align Technology, Inc.
- iTero Lumina Pro DOA — Align Technology, Inc.
- iTero Lumina Pro Mobile — Align Technology, Inc.
- iTero Lumina Pro Mobile Upgrade — Align Technology, Inc.
- iTero Lumina Pro Upgrade — Align Technology, Inc.
- iTero Lumina Pro Wand Barrier Sleeves — Align Technology, Inc.
- iTero Lumina Pro intraoral scanning unit — Align Technology, Inc.
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
- Align Technology, Inc.
Sources (1)
- FDA UDI 59e03c98-2943-4e13-8a7c-fb9fc3848a21 34 fields · synced May 31, 2026