# K983285: Engle Dental Family of Delivery Systems

- Pathway: 510(k) (Traditional)
- Applicant: Engle Dental Systems
- Decided: Nov 4, 1998 after 47 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 its predicate without a number.
- (no number) 1400 XL Deluxe Dental Delivery System: named in the summary without a submission number

## Indications for use
The Engle Dental Systems Family of Dental Units are medical devices to be used by dentists, technicians, and hygienists in dental procedures. The units will deliver air and water to the ends of the hand pieces that the dentists use in the procedures they perform on their patients. It is designed to operate dental handpiece attachments and suction instruments. The Engle Dental Systems Family of Dental Units feature numerous customer-requested options such as in-line air and water filters, special foot controls, assistant's arms.

Source page: https://510kreport.com/device/K983285
Methodology: https://510kreport.com/methodology