510(k) Report

FDA applicant

Kavo Dental Technologies, LLC

Charlotte, NC1 decision2017–20171 recall

FDA records 1 decision for Kavo Dental Technologies, LLC (Charlotte, NC) in 2017: 1 510(k) clearance. All are in product code MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Kavo Dental Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2017high 1 (2019) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Kavo Dental Technologies, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K172918DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)Kavo Dental Technologies, LLC · 20172cite it

What has FDA decided for it lately?

  • K172918DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)Kavo Dental Technologies, LLC · 20171 recall

The one decision as Kavo Dental Technologies, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K172918DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a…Apr 29, 2019Class II

Other applicant names beginning “Kavo”

FDA records each applicant name separately; these may or may not be the same firm.

Kavo America 24Kavo Dental Corporation 2Kavo DO Brasil Industria E Comercio Ltda 1