510(k) Report

510(k) · Cleared

Recalled · 2008

Vanadium Excavators Sizes 0-6

K834055510(k) TraditionalCleared Feb 21, 198490-day reviewClass I21 CFR 872.4565Recalls 8

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Henry Schein, Inc. · EKC Excavator, Dental, Operative

Cleared on Feb 21, 1984 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 8 times.

Decided
Feb 21, 1984
Review
90 days
Class
Class I
Product code
EKC
Recalls
8
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K834055Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EKC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 14, 2008Not classifiedZ-0152-2010Component change controlThe tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
Nov 14, 2008Not classifiedZ-0153-2010Component change controlThe tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
Nov 14, 2008Not classifiedZ-0154-2010Component change controlThe tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
Nov 14, 2008Not classifiedZ-0157-2010Component change controlThe tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
Nov 14, 2008Not classifiedZ-0151-2010Component change controlThe tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
Nov 14, 2008Not classifiedZ-0156-2010Component change controlThe tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
Nov 14, 2008Not classifiedZ-0158-2010Component change controlThe tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
Nov 14, 2008Not classifiedZ-0155-2010Component change controlThe tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EKC devices

EKC Excavator, Dental, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKC

FDA has decided no EKC device since 2007.

Median 510(k) review, days · EKC

Too few EKC 510(k)s in any year since 2007 to give a median.

Recalls per year · EKC

8in 2008

2008: 8
2007high 8 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EKC

1in 2025

2015: 12016: 22022: 22024: 12025: 1
2007high 2 (2016) · low 0 (2007)2025

MAUDE reports naming product code EKC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—80
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—02
20170—00
20180—00
20190—00
20200—00
20210—00
20220—02
20230—00
20240—01
20250—01
20260—0—

More from Henry Schein, Inc.

8 FDA decisions under this applicant name. See the company

  • K041580ImagerayiHenry Schein, Inc. · 2004
  • K862384Schein AP-1 Air Polishing UnitHenry Schein, Inc. · 1986
  • K862385Schein Bleaching UnitHenry Schein, Inc. · 1986
  • K841199Fiberglass Mouth MirrorsHenry Schein, Inc. · 1984
  • K834056Schein Cotton Rolls, Non-SterileHenry Schein, Inc. · 1984

Recent decisions in EKC

The EKC category page

  • K8517221285/5 to 1295 Various Types of Dental ExcavatorsArtiberia · 1985

https://510kreport.com/device/K834055 · printed Nov 4, 2026

Cite this page

510(k) Report. “K834055: Vanadium Excavators Sizes 0-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K834055

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026