Cleared Traditional

K863709 - CHALLENGE ORTHODONTIC BONDING ADHESIVE

K863709 is an FDA 510(k) clearance for CHALLENGE ORTHODONTIC BONDING 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 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

FDA 510(k) Submission Details - K863709

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
Combination Product No
PCCP Authorized No
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.

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 K863709.
RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)
K875143 · Reliance Orthodontic Products, Inc. · Feb 1988
EXCEL FAST SET
K875144 · Reliance Orthodontic Products, Inc. · Feb 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