DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)— 510(k) K172918

Name: FDA 510(k) clearance K172918
Creator: U.S. Food and Drug Administration
Published: 2017-12-18

Substantially Equivalent

Kavo Dental Technologies, LLC

FDA 510(k) clearance K172918 for DEXIS Titanium, KaVo IXS HD (Size 1, Size 2), Substantially Equivalent on 2017-12-18. Applicant: Kavo Dental Technologies, LLC. Device class: 2.

Clearance details

Applicant: Kavo Dental Technologies, LLC
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2017-09-25
Decision date: 2017-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K172918

K-number listed on FDA's recall record

Z-1387-2019 — DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.Class II·Terminated·KaVo Dental Technologies LLC·20190429

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172918.

Data sourced from openFDA. This site is unofficial and independent of the FDA.