Cleared Traditional

K061322 - PORCELAIN PRIMER

K061322 is the FDA 510(k) clearance for PORCELAIN PRIMER by J. Morita USA, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K061322 · J. Morita USA, Inc. · Dental device
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Jun 2006
Decision
22d
Days
Class 2
Risk

K061322 is an FDA 510(k) clearance for the PORCELAIN PRIMER. 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 June 2, 2006 after a review of 22 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 J. Morita USA, Inc. devices

Submission Details

510(k) Number K061322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2006
Decision Date June 02, 2006
Days to Decision 22 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
105d faster than avg
Panel avg: 127d · This submission: 22d
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 K061322.
CLEARFIL DC BOND
K062382 · Kuraray Medical, Inc. · Sep 2006
BOSWORTH DENTIN RESIN
K061611 · Harry J. Bosworth Co. · Sep 2006
EXCEL BOND DC, MODEL 28-200100
K060882 · J. Morita USA, Inc. · Sep 2006
OPTIBOND ALL-IN-ONE
K060469 · Sybron Dental Specialties, Inc. · Mar 2006
FUTURABOND NR SINGLE DOSE
K053392 · Voco GmbH · Dec 2005
ECLIPSE BONDING AGENT
K051707 · Dentsply Intl. · Jul 2005