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DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

by KaVo Dental Technologies, LLC

510(k) K172918

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK172918 Date18 Dec 2017ClearedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUH
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent