Cleared Traditional

K040079 - M.L. PRIMER

K040079 is the FDA 510(k) clearance for M.L. PRIMER by Shofu Dental Corp.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K040079 · Shofu Dental Corp. · Dental device
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Sep 2004
Decision
238d
Days
Class 2
Risk

K040079 is an FDA 510(k) clearance for the M.L. PRIMER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Shofu Dental Corp. (San Marcos, US). The FDA issued a Cleared decision on September 9, 2004 after a review of 238 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 Shofu Dental Corp. devices

Submission Details

510(k) Number K040079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2004
Decision Date September 09, 2004
Days to Decision 238 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
111d slower than avg
Panel avg: 127d · This submission: 238d
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 220
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K040079.
XENO ADHESIVE WITH ACTIVATOR
K051463 · Dentsply Intl. · Jul 2005
ALL-IN-ONE
K050647 · Bisco, Inc. · Apr 2005
FUTURABOND NR
K042670 · Voco GmbH · Nov 2004
G-BOND
K041471 · GC America, Inc. · Jun 2004
PERMAQUICK SE BONDING SYSTEM
K032626 · Ultradent Products, Inc. · Dec 2003
COMP. E
K032179 · Parkell, Inc. · Sep 2003