Cleared Traditional

K961409 - PORTA'PURE/DENTAL

K961409 is an FDA 510(k) clearance for PORTA'PURE/DENTAL, manufactured by Water Solution Technologies. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K961409 · Water Solution Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
62d
Days
Class 1
Risk

K961409 is an FDA 510(k) clearance for the PORTA'PURE/DENTAL. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Water Solution Technologies (Carlsbad, US). The FDA issued a Cleared decision on June 12, 1996 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Water Solution Technologies devices

FDA 510(k) Submission Details - K961409

510(k) Number K961409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1996
Decision Date June 12, 1996
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
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 171
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K961409.
A-DEC SELF-CONTAINED WATER SYSTEM
K962665 · A-Dec, Inc. · Aug 1996
SPIRIT S1/S2
K962071 · Pelton & Crane Co. · Aug 1996
GENERAL PURPOSE DENTAL TRAY
K962527 · Medcare Medical Group, Inc. · Aug 1996
BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K960556 · Scitech Solutions, Inc. · May 1996
POWERS ANTI-BACTERIAL VALVE
K954471 · Powers Dental & Medical Technology, Inc. · Apr 1996
A-DEC PERFORMER CONTROL UNIT
K960506 · A-Dec, Inc. · Mar 1996