# K834055: Vanadium Excavators Sizes 0-6

- Pathway: 510(k) (Traditional)
- Applicant: Henry Schein, Inc.
- Decided: Feb 21, 1984 after 90 days
- Product code: EKC (Excavator, Dental, Operative)
- Device class: 1
- Regulation: 21 CFR 872.4565
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 14, 2008 · Not classified · Z-0152-2010: The 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, 2008 · Not classified · Z-0153-2010: The 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, 2008 · Not classified · Z-0154-2010: The 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, 2008 · Not classified · Z-0157-2010: The 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, 2008 · Not classified · Z-0151-2010: The 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, 2008 · Not classified · Z-0156-2010: The 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, 2008 · Not classified · Z-0158-2010: The 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, 2008 · Not classified · Z-0155-2010: The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.

Source page: https://510kreport.com/device/K834055
Methodology: https://510kreport.com/methodology