# K092851: Model GDCH-2000

- Pathway: 510(k) (Traditional)
- Applicant: Global Dental Direct, Inc.
- Decided: Sep 29, 2009 after 13 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032756 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032756: A-Dec 532/533 Delivery System Model, 532/533, A-Dec, Inc. (2003) Summary page 1.

## Indications for use
Global GDCH - 2000 is a dental operative unit attached to patient chair. The dental operative unit is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device also functions to deliver air, water and vacuum to the dental devices/accessories. The device is attached to dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K092851
Methodology: https://510kreport.com/methodology