# K981565: Bioclear Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Waggoner Product Development
- Decided: Oct 15, 1998 after 167 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 K962071 (1996). 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)
- K962071: Spirit S1/S2, Pelton & Crane Co. (1996) Summary page 2.

## Indications for use
BioClear Concentrate is intended to be diluted daily into tap water and placed in an independent dental reservoir bottle system, which would act as the sole supply of water for the Dental Operative Unit. There, the diluted BioClear Concentrate would act as a constantly present, potable, antimicrobial agent. It has been found to aid in the control of the microbial population in dental unit waterlines.

Source page: https://510kreport.com/device/K981565
Methodology: https://510kreport.com/methodology