Cleared Traditional

K010544 - VERTEX L/C ORTHODONTIC DIRECT BONDING P...

K010544 is the FDA 510(k) clearance for VERTEX L/C ORTHODONTIC DIRECT BONDING P... by Apex Dental Materials, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K010544 · Apex Dental Materials, Inc. · Dental device
Download Printable Device Report (PDF)
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Aug 2001
Decision
168d
Days
Class 2
Risk

K010544 is an FDA 510(k) clearance for the VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Apex Dental Materials, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 10, 2001 after a review of 168 days - an extended review 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: 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 Apex Dental Materials, Inc. devices

Submission Details

510(k) Number K010544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2001
Decision Date August 10, 2001
Days to Decision 168 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 127d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K010544.
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115 · Pulpdent Corp. · Feb 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · Pulpdent Corp. · Feb 2002
FIRST SPEP
K012032 · Bisco, Inc. · Sep 2001
IMPROVED ENLIGHT LV
K001881 · Sybron Dental Specialties, Inc. · Aug 2000
LIGHT-CURED ORTHODONTIC BAND CEMENT
K001446 · Scientific Pharmaceuticals, Inc. · Jul 2000
SOLO ORTHO 2
K994309 · Sybron Dental Specialties, Inc. · Mar 2000