← Back to catalogue
iTero Element 5D US Laptop Configuration
FDA UDIEUDAMEDFDA 510(k)Class II (US FDA UDI)
510(k) K193659
Identity
- Trade Name
- iTero Element 5D US Laptop Configuration FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Scanner FDA UDI
- Model / Reference
- 209155 FDA UDI
- Description
- Scanner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020622 FDA UDI
- 510(k) Number
- K193659 FDA UDI
- FDA Product Code
- NTK FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1745 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
No
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: Dental milling system, CAD/CAM, chairside
iTero Element 5D US Laptop Configuration by Align Technology, Inc. — Class II — MDR, FDA_510K — listed in FDA GUDID, EUDAMED, FDA 510(k)
Similar devices
Also classified as Dental milling system, CAD/CAM, chairside.
- Shofu Block HC — SHOFU DENTAL CORP. · Class II
- Shofu Block HC — SHOFU DENTAL CORP. · Class II
- DENTSPLY SIRONA® — Shining 3D Tech Co., Ltd. · Class II
- SHOFU DISK — SHOFU DENTAL CORP. · Class II
- TRIOS® — 3shape Trios A/S · Class II
- CS 3500 3D Scanner Collar — CARESTREAM HEALTH, INC. · Class II
- TRIOS® — 3shape Trios A/S · Class II
- KAVO X PRO REUSABLE TIP SUPPORT — PaloDEx Group Oy · Class II
Cleared under the same submission
K193659 also covers:
- DOA Kit, 5D US Plus — Align Technology, Inc.
- DOA Kit, Element 5D Plus Lite — Align Technology, Inc.
- Packed 5D Plus Lite Scanning Unit, RMA — Align Technology, Inc.
- Packed 5D Plus US Scanning Unit, RMA — Align Technology, Inc.
- iTero 5D Scanning Unit — Align Technology, Inc.
- iTero Element 5D LC Upgrade, Kit US — Align Technology, Inc.
- iTero Element 5D Plus Ready US Cart configuration — Align Technology, Inc.
- iTero Element 5D Plus Ready US Mobile configuration — Align Technology, Inc.
- iTero Element 5D Plus US cart configuration — Align Technology, Inc.
- iTero Element 5D Plus US mobile configuration — Align Technology, Inc.
- iTero Element 5D Plus US wand upgrade — Align Technology, Inc.
- iTero Element 5D Plus upgrade cart configuration — Align Technology, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA 510(k) | United States | FDA_510K | K193659 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Align Technology, Inc.
Sources (3)
- FDA UDI a9bd53c0-aadb-4df7-97e9-039206e9b6fe 58 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026
- FDA 510(k) K193659 1 fields · synced May 25, 2026