Cleared Traditional

K992195 - QUANTEC-E IRRIGATION SYSTEM 2

K992195 is an FDA 510(k) clearance for QUANTEC-E IRRIGATION SYSTEM 2, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K992195 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
101d
Days
Class 1
Risk

K992195 is an FDA 510(k) clearance for the QUANTEC-E IRRIGATION SYSTEM 2. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on October 8, 1999 after a review of 101 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 Sybron Dental Specialties, Inc. devices

FDA 510(k) Submission Details - K992195

510(k) Number K992195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1999
Decision Date October 08, 1999
Days to Decision 101 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
26d faster than avg
Panel avg: 127d · This submission: 101d
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 158
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