Cleared Traditional

K923399 - CHALLENGE II - PASTE ADHESIVE

K923399 is the FDA 510(k) clearance for CHALLENGE II - PASTE ADHESIVE by Ormco Corp.. It is a Class 2 Dental device (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

Submission Details

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
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.

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 65
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K923399.
FUJI ORTHO LC
K950556 · GC America, Inc. · Mar 1995
SYSTEM 1
K940845 · Sybron Dental Specialties, Inc. · Mar 1994
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
K921283 · Jeneric/Pentron, Inc. · Dec 1992
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K911286 · Pulpdent Corp. · Jul 1991
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K890834 · Scientific Pharmaceuticals, Inc. · May 1989
ORTHO-SEAL
K883465 · Bisco, Inc. · Oct 1988