# K760404: BI-Centric System

- Pathway: 510(k) (Traditional)
- Applicant: Pelton & Crane Co.
- Decided: Aug 23, 1976 after 14 days
- Product code: KLC (Chair, Dental, With Operative Unit)
- Device class: 1
- Regulation: 21 CFR 872.6250
- Recalls of this device: 5 (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
- Feb 24, 2010 · Not classified · Z-1326-2010: Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
- Feb 24, 2010 · Not classified · Z-1325-2010: Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
- Feb 24, 2010 · Not classified · Z-1179-2010: Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
- Feb 24, 2010 · Not classified · Z-1324-2010: Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
- Feb 24, 2010 · Not classified · Z-1180-2010: Magnetic headrests may affect patients with implantable pacemakers and defibrillators.

Source page: https://510kreport.com/device/K760404
Methodology: https://510kreport.com/methodology