Cleared Traditional

K040079 - M.L. PRIMER

K040079 is an FDA 510(k) clearance for M.L. PRIMER, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K040079

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.

KLE Device Classification - Class 2, Special Controls

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 353
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K040079.
QUADRANT UNIT-1-BOND
K042806 · Cavex Holland BV · Nov 2004
S&C-SELF ETCH PR-BOND
K042614 · S & C Polymer GmbH · Nov 2004
FUTURABOND NR
K042670 · Voco GmbH · Nov 2004
COMPOSITE/COMPOMER REPAIR KIT
K041960 · Dmg USA, Inc. · Aug 2004
G-BOND
K041471 · GC America, Inc. · Jun 2004
XENO NM LIGHT CURED DENTAL ADHESIVE
K041343 · Dentsply International · Jun 2004