Cleared Traditional

K973996 - CLEARLINE PLUS, DENTAL WATERLINE FILTER

K973996 is an FDA 510(k) clearance for CLEARLINE PLUS, manufactured by Scitech Solutions, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K973996 · Scitech Solutions, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
106d
Days
Class 1
Risk

K973996 is an FDA 510(k) clearance for the CLEARLINE PLUS, DENTAL WATERLINE FILTER. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Scitech Solutions, Inc. (Seatttle, US). The FDA issued a Cleared decision on February 4, 1998 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Scitech Solutions, Inc. devices

FDA 510(k) Submission Details - K973996

510(k) Number K973996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1997
Decision Date February 04, 1998
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 123
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K973996.
TELICAM
K980474 · Dental/Medical Diagnostic Systems, Inc. · Apr 1998
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
K974487 · Asi Medical, Inc. · Feb 1998
TRUE VISION, TRUE VISION II
K974542 · Medical Dynamics, Inc. · Feb 1998
DENTAL TRAY, STERILE, DISPOSABLE
K974238 · Trinity Laboratories, Inc. · Feb 1998
VISTACAM OMNI AND VIASTCAM OMNI (IC)
K974204 · Air Techniques, Inc. · Jan 1998
DENTALVIEW PERIOVIEW SYSTEM
K973492 · Dentalview, Inc. · Oct 1997