Cleared Traditional

K915511 - MIRAGE COMPLETE KIT AND MIRAGE ABC KIT

K915511 is an FDA 510(k) clearance for MIRAGE COMPLETE KIT AND MIRAGE ABC KIT, manufactured by Mirage Dental Systems. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K915511 · Mirage Dental Systems · Dental device
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Mar 1992
Decision
88d
Days
Class 2
Risk

K915511 is an FDA 510(k) clearance for the MIRAGE COMPLETE KIT AND MIRAGE ABC KIT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Mirage Dental Systems (Kansas City, US). The FDA issued a Cleared decision on March 6, 1992 after a review of 88 days - a notably fast clearance cycle.

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: 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 Mirage Dental Systems devices

FDA 510(k) Submission Details - K915511

510(k) Number K915511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date March 06, 1992
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 383
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K915511.
COLTENE A.R.T. BOND
K922615 · Coltene/Whaledent, Inc. · Aug 1992
DURAFILL BOND
K921701 · Heraeus Kulzer, Inc. · Jun 1992
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · 3M Company · Mar 1992
SR-ISOSIT SPECTRA LINK SYSTEM
K910069 · Ivoclar North America, Inc. · Mar 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992
ESPE(R) -SIL
K913965 · Espe GmbH (Us) · Dec 1991