# K973996: Clearline Plus, Dental Waterline Filter

- Pathway: 510(k) (Traditional)
- Applicant: Scitech Solutions, Inc.
- Decided: Feb 4, 1998 after 106 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963548: Dentapure Dental Unit Water Line Filter-Iodinated, Mrlb Intl., Inc. (1997) Summary page 7.
- K930144: The Scitech One-Day Filter, Scitech Solutions, Inc. (1994) Summary page 1.
- K960556: Bacstop Dental Anti-Retraction Check Valve, Scitech Solutions, Inc. (1996) Summary page 1.

## Most influential descendants
- K982009: One Week Backstop Dental Anti-Retraction Check Valve (1998), 0 descendants of its own

## Indications for use
CLEARLINE PLUS™ is a disposable, combined 0.22 micron filter and anti-retraction check valve for use in dental unit water lines. It is intended to be used, in line, as a means of controlling bacteriological contaminants in the dental water and preventing the retraction of orally contaminated fluids into the dental line. It is to be used for all patients and changed every week, or.5 working days. CLEARLINE PLUS™ is to be installed within the last several inches of tubing, before the dental handpiece, air/water syringe or ultrasonic scaler. The filter comprises a 0.2 micron bacterial retentive membrane to reduce bacteriological contaminants in the dental water. The check valve opens only when sufficient pressure is applied (1.5 psi) and snaps closed when the pressure drops below this point, thereby sealing the line against any backflow. The device is inserted by connection to luer mounts placed permanently in line.

Source page: https://510kreport.com/device/K973996
Methodology: https://510kreport.com/methodology