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IXS S2 Kit, CT, US, FR-CA 1.013.9712

by Dental Imaging Technologies Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 NumberD090101397120 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1387-2019 FDA Class II initiated 29 Apr 2019

    The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
IXS S2 Kit, CT, US, FR-CA
Generic Name
Dental digital imaging sensor, intraoral
Model / Reference
1.013.9712
Primary DI / UDI-DI
D090101397120
510(k) Number
FDA Product Code
MUH
GMDN Term
Dental digital imaging sensor, intraoral
Device Class
Class II
Regulation Number
872.1800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K172918)

Show all (12)

Other devices from Dental Imaging Technologies Corporation

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Properties

  • Serial Number

Other properties (13)

  • 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
  • Manufacturing Date: No