Cleared Traditional

K060882 - EXCEL BOND DC

K060882 is the FDA 510(k) clearance for EXCEL BOND DC by J. Morita USA, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K060882 · J. Morita USA, Inc. · Dental device
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Sep 2006
Decision
154d
Days
Class 2
Risk

K060882 is an FDA 510(k) clearance for the EXCEL BOND DC, MODEL 28-200100. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 154 days - an extended review 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: 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 J. Morita USA, Inc. devices

Submission Details

510(k) Number K060882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2006
Decision Date September 01, 2006
Days to Decision 154 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 127d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K060882.
PREMIER SELF-ETCHING BOND ENHANCER
K061998 · Premier Dental Products Co. · Oct 2006
CLEARFIL DC BOND
K062382 · Kuraray Medical, Inc. · Sep 2006
BOSWORTH DENTIN RESIN
K061611 · Harry J. Bosworth Co. · Sep 2006
PORCELAIN PRIMER
K061322 · J. Morita USA, Inc. · Jun 2006
OPTIBOND ALL-IN-ONE
K060469 · Sybron Dental Specialties, Inc. · Mar 2006
FUTURABOND NR SINGLE DOSE
K053392 · Voco GmbH · Dec 2005