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iTero Element™ 5D imaging system 217618

by Align Technology, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816063023029 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
iTero Element™ 5D imaging system
Generic Name
Dental milling system, CAD/CAM, chairside
Model / Reference
217618
Primary DI / UDI-DI
00816063023029
510(k) Number
FDA Product Code
NTK
GMDN Term
Dental milling system, CAD/CAM, chairside
Device Class
Class II
Regulation Number
872.1745
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K193659)

Show all (12)

Other devices from Align Technology, Inc.

See all devices from Align Technology, Inc. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

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