Cleared Traditional

K923399 - CHALLENGE II - PASTE ADHESIVE

K923399 is an FDA 510(k) clearance for CHALLENGE II - PASTE ADHESIVE, manufactured by Ormco Corp.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K923399 · Ormco Corp. · Dental device
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Oct 1992
Decision
109d
Days
Class 2
Risk

K923399 is an FDA 510(k) clearance for the CHALLENGE II - PASTE ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Ormco Corp. (Glendora, US). The FDA issued a Cleared decision on October 27, 1992 after a review of 109 days - within the typical 510(k) review window.

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 Ormco Corp. devices

FDA 510(k) Submission Details - K923399

510(k) Number K923399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date October 27, 1992
Days to Decision 109 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
18d faster than avg
Panel avg: 127d · This submission: 109d
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 K923399.
ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST
K930614 · Wallace A. Erickson & Co. · Jun 1993
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
K921283 · Jeneric/Pentron, Inc. · Dec 1992
ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND
K921044 · Wallace A. Erickson & Co. · Nov 1992
THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II
K921245 · Ormco Corp. · May 1992
IMPROVED SEQUENCE LIGHT CURE ADHESIVE
K921385 · Ormco Corp. · Apr 1992
ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL
K914317 · Confi-Dental Products Co. · Mar 1992