# K981171: Eradic-All

- Pathway: 510(k) (Traditional)
- Applicant: Theratechnologies, Inc.
- Decided: Dec 2, 1998 after 245 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: 2 generations back to K930144 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971278: Pure Company Fluid Delivery System, Pure Co. (1997) Summary page 1.
- K963548: Dentapure Dental Unit Water Line Filter-Iodinated, Mrlb Intl., Inc. (1997) Summary page 1.
- K930144: The Scitech One-Day Filter, Scitech Solutions, Inc. (1994) Summary page 1.
- K882491: Cutting Fluid System for Dental High Speed Drills, Steri-Sol, Inc. (1988) Summary page 1.

## Indications for use
To isolate water delivery lines in the dental operatory unit and reduce the contamination due to biofilm to improve the quality of water supplied to dental handpieces.and other dental mstrumcnts

Source page: https://510kreport.com/device/K981171
Methodology: https://510kreport.com/methodology