Cleared Traditional

QUIKSEAL (K923895) - FDA 510(k) Clearance

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

K923895 · Mirage Dental Systems · Dental device
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Dec 1992
Decision
141d
Days
Class 2
Risk

K923895 is an FDA 510(k) clearance for the QUIKSEAL. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Mirage Dental Systems (Kansas City, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Mirage Dental Systems devices

Submission Details

510(k) Number K923895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date December 23, 1992
Days to Decision 141 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 127d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 25
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K923895.
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K991909 · Dentsply Intl. · Aug 1999
DELTON FS DIRECT DELIVERY SYSTEM
K982564 · Dentsply Intl. · Oct 1998
DELTON F PIT & FISSURE SEALANT
K951296 · Dentsply Intl. · May 1995
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341 · Dentsply Intl. · Apr 1990
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · Dentsply Intl. · Feb 1988
PRISMA METAL OPAQUERS
K862660 · Dentsply Intl. · Jul 1986