# K963050: Tradition P, Push Button Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Dental Products Corp.
- Decided: Oct 11, 1996 after 66 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K983168: Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S Avant HS 100 & Avant HS 200 (1998), 0 descendants of its own

## Recalls of this device
- Oct 14, 2003 · Not classified · Z-0154-04: Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
- Oct 14, 2003 · Not classified · Z-0155-04: Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
- Oct 14, 2003 · Not classified · Z-0156-04: Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.

Source page: https://510kreport.com/device/K963050
Methodology: https://510kreport.com/methodology