Cleared Traditional

K061322 - PORCELAIN PRIMER (FDA 510(k) Clearance)

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

K061322 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 417
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K061322.
Porcelain Etch Gel
K260430 · Belport Company, Inc., Gingi-Pak · Apr 2026
Adhese 2
K252450 · Ivoclar Vivadent, Inc. · Mar 2026
Bond-PR™ Universal Adhesive
K260682 · Premier Dental Products Company · Mar 2026
VITA VMLC Primer
K251587 · Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · Feb 2026
els unibond
K252151 · Saremco Dental AG · Dec 2025
MAGNABOND SE
K252469 · Dmp Dental Industry S.A. · Nov 2025