Cleared Traditional

K000189 - PQ1

K000189 is an FDA 510(k) clearance for PQ1, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K000189 · Ultradent Products, Inc. · Dental device
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May 2000
Decision
111d
Days
Class 2
Risk

K000189 is an FDA 510(k) clearance for the PQ1. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K000189

510(k) Number K000189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date May 11, 2000
Days to Decision 111 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
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 372
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K000189.
SOLOBOND PLUS
K003153 · Voco GmbH · Nov 2000
CERAM-PRIME
K002502 · S & C Polymer GmbH · Nov 2000
MODIFICATION TO PROMPT L-POP
K001494 · Espe Dental AG · Jul 2000
KERR GEL ETCHANT
K000954 · Sybron Dental Specialties, Inc. · Apr 2000
BOND 1 C & B
K994359 · Jeneric/Pentron, Inc. · Mar 2000
RESIN TOOTH BONDING AGENT
K994302 · Parkell, Inc. · Feb 2000