# K973765: BIO-2000

- Pathway: 510(k) (Traditional)
- Applicant: Micrylium Laboratories
- Decided: Nov 4, 1998 after 398 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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

## Indications for use
1. For use in pressurized self-contained water devices. 2. For use in cleaning lines in dental units by leaving the solution (Bio2000), dispensed by a pressurized device, overnight (similar period of time) or use continuously. Cleaning lines refers to the reduction of microbial contamination. 3. For use in operative procedures to dedicated coolant (water) line for air or electric driven handpieces and scalers. Use of this device and solution will increase cutting efficiency and decrease the bad odors and tastes that occur during operative procedures while decreasing microbial contamination of the tubing.

Source page: https://510kreport.com/device/K973765
Methodology: https://510kreport.com/methodology