# K971278: Pure Company Fluid Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Pure Co.
- Decided: Jul 3, 1997 after 87 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K990479: Hygeniclear WKR 1, Water-Delivery Device Ultraclear (1999), 0 descendants of its own
- K981171: Eradic-All (1998), 0 descendants of its own

## Indications for use
The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air. The operation of the the Fluid Delivery System is facilitated by a rotary switch on the control face that permits switching between the contents of the two bottles being used. There is a built-in pressure relief valve that limits pressure in the bottles to 40psi as a safety feature. The control face panel also has a quick disconnect that allows the solutions in the bottle selected to be used in an external dental device.

Source page: https://510kreport.com/device/K971278
Methodology: https://510kreport.com/methodology