Cleared Traditional

K020394 - APC PLUS ADHESIVE

K020394 is an FDA 510(k) clearance for APC PLUS ADHESIVE, manufactured by 3M Unitek. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K020394 · 3M Unitek · Dental device
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Apr 2002
Decision
65d
Days
Class 2
Risk

K020394 is an FDA 510(k) clearance for the APC PLUS ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by 3M Unitek (Monrovia, US). The FDA issued a Cleared decision on April 12, 2002 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 3M Unitek devices

FDA 510(k) Submission Details - K020394

510(k) Number K020394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2002
Decision Date April 12, 2002
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 134
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K020394.
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
K030036 · Pulpdent Corporation · Mar 2003
SOLO ORTHO 3
K020502 · Sybron Dental Specialties, Inc. · May 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · GC America, Inc. · Apr 2002
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133 · Pulpdent Corp. · Mar 2002
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
K014138 · Pulpdent Corp. · Mar 2002
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115 · Pulpdent Corp. · Feb 2002