Itero Element 108064
Itero Element 108064 is a dental milling system (FDA Class II; FDA product code NOF) made by Align Technology Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00816063020141), registry data as of 8 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816063020141 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00816063020141
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Itero Element
- Generic name
- Dental milling system, CAD/CAM, chairside
- Model / reference
- 108064
- Primary DI / UDI-DI
- 00816063020141
- FDA product code
- NOF
- GMDN term
- Dental milling system, CAD/CAM, chairside
- Device class
- Class II
- Regulation number
- 872.3661
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NOF (System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations).
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- CAD/CAM Software 6733336 by SIRONA Dental Systems GmbH