Cleared Traditional

QUELL DESENSITIZER (K010957) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010957 · Jeneric/Pentron, Inc. · Dental device
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Jun 2001
Decision
87d
Days
Class 2
Risk

K010957 is an FDA 510(k) clearance for the QUELL DESENSITIZER. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on June 25, 2001 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 Jeneric/Pentron, Inc. devices

Submission Details

510(k) Number K010957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2001
Decision Date June 25, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 33
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K010957.
VOCO PROFLUORID VARNISH
K080814 · Voco GmbH · Jul 2008
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · Dentsply Intl. · Aug 2002
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822 · Dentsply Intl. · Nov 1999
FLUOR PROTECTOR
K946032 · Ivoclar North America, Inc. · Mar 1995
DENTIN PROTECTOR
K901915 · Ivoclar North America, Inc. · Jun 1990