Cleared Traditional

K884137 - MIRAGE BOND

K884137 is an FDA 510(k) clearance for MIRAGE BOND, manufactured by Chameleon Dental Products, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K884137 · Chameleon Dental Products, Inc. · Dental device
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Dec 1988
Decision
68d
Days
Class 2
Risk

K884137 is an FDA 510(k) clearance for the MIRAGE BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Chameleon Dental Products, Inc. (Kansas City, US). The FDA issued a Cleared decision on December 7, 1988 after a review of 68 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 Chameleon Dental Products, Inc. devices

FDA 510(k) Submission Details - K884137

510(k) Number K884137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date December 07, 1988
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 128d · This submission: 68d
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 384
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K884137.
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989
TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
K885010 · Coe Laboratories, Inc. · Feb 1989
KETAC-GLAZE
K884752 · Espe GmbH (Us) · Jan 1989
XR PRIMER
K880684 · Kerr Corporation (Danbury) · May 1988
TEMPORARY DISCLOSING SOLUTION
K874074 · Dentsply Intl. · Dec 1987
CLEARFIL PHOTO BOND
K872959 · Kuraray Co. · Nov 1987