Cleared Traditional

CHAMELEON BONDING KIT (K854803) - FDA 510(k) Clearance

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

K854803 · Pentron Corp. · Dental device
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Mar 1986
Decision
92d
Days
Class 2
Risk

K854803 is an FDA 510(k) clearance for the CHAMELEON BONDING KIT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pentron Corp. (Wallingford, US). The FDA issued a Cleared decision on March 4, 1986 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Pentron Corp. devices

Submission Details

510(k) Number K854803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1985
Decision Date March 04, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K854803.
RESTOR (COMET)*DENTAL RESTORATIVE
K861833 · Johnson & Johnson Professionals, Inc. · Jul 1986
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
K861899 · 3M Company · Jun 1986
P-50 LIGHT CURED RESIN BONDED CERAMIC
K861740 · 3M Company · May 1986
DENTAL CEMENT
K853431 · Dentsply Intl. · Oct 1985
RESTORE*
K851929 · Johnson & Johnson Professionals, Inc. · Jul 1985
BIOGLOSS
K852659 · Dentsply Intl. · Jul 1985