Cleared Traditional

K863709 - CHALLENGE ORTHODONTIC BONDING ADHESIVE

K863709 is the FDA 510(k) clearance for CHALLENGE ORTHODONTIC BONDING ADHESIVE by Ormco Corp.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K863709 · Ormco Corp. · Dental device
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Jan 1987
Decision
120d
Days
Class 2
Risk

K863709 is an FDA 510(k) clearance for the CHALLENGE ORTHODONTIC BONDING 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 January 21, 1987 after a review of 120 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 K863709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date January 21, 1987
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
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 K863709.
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K890834 · Scientific Pharmaceuticals, Inc. · May 1989
ORTHO-SEAL
K883465 · Bisco, Inc. · Oct 1988
ORMCO GEL-ETCH
K871591 · Scientific Pharmaceuticals, Inc. · May 1987
ACCLAIM* BRACKET ADHESIVE
K864008 · Johnson & Johnson Professionals, Inc. · Oct 1986
ESPE NIMETIC-GRIP
K844844 · Espe GmbH (Us) · Feb 1986
EXCEL BRACKET ADHESIVE
K854050 · Johnson & Johnson Professionals, Inc. · Nov 1985