Cleared Traditional

K991035 - QUANTEC-E IRRIGATION SYSTEM

K991035 is the FDA 510(k) clearance for QUANTEC-E IRRIGATION SYSTEM by Sybron Dental Specialties, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K991035 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
87d
Days
Class 1
Risk

K991035 is an FDA 510(k) clearance for the QUANTEC-E IRRIGATION SYSTEM. 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 June 24, 1999 after a review of 87 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K991035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date June 24, 1999
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 56
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K991035.
3181 DUO DELIVERY SYSTEM
K000968 · A-Dec, Inc. · May 2000
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
K000112 · Dentsply Intl. · Apr 2000
QUANTEC-E IRRIGATION SYSTEM 2
K992195 · Sybron Dental Specialties, Inc. · Oct 1999
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937 · Welch Allyn, Inc. · Aug 1998
DENTAL TRAY, STERILE, DISPOSABLE
K974238 · Trinity Laboratories, Inc. · Feb 1998