# K964619: Delivery System (SDS 1400 XL)/Delivery System Cuspidor (SDS1450,SDS1650 XL)

- Pathway: 510(k) (Traditional)
- Applicant: Sds Dental, Inc.
- Decided: Jan 22, 1997 after 65 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
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. The FDA summary names no predicate by number.

## Indications for use
The 1400 XL Deluxe Dental Delivery System is designed to conveniently position the dentist's dynamic instruments for use during dental procedures.

Source page: https://510kreport.com/device/K964619
Methodology: https://510kreport.com/methodology