Cleared Traditional

K860959 - DEPENDABOND

K860959 is an FDA 510(k) clearance for DEPENDABOND, manufactured by Ortho Source. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K860959 · Ortho Source · Dental device
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Mar 1986
Decision
12d
Days
Class 2
Risk

K860959 is an FDA 510(k) clearance for the DEPENDABOND. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Ortho Source (North Hollywood, US). The FDA issued a Cleared decision on March 25, 1986 after a review of 12 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho Source devices

FDA 510(k) Submission Details - K860959

510(k) Number K860959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1986
Decision Date March 25, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 127d · This submission: 12d
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 151
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K860959.
ORMCO GEL-ETCH
K871591 · Scientific Pharmaceuticals, Inc. · May 1987
CHALLENGE ORTHODONTIC BONDING ADHESIVE
K863709 · Ormco Corp. · Jan 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
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523 · Dentsply Intl. · Nov 1985