Cleared Traditional

K800392 - BRACKET BONDING SYSTEM METAL & PLASTIC

K800392 is an FDA 510(k) clearance for BRACKET BONDING SYSTEM METAL & PLASTIC, manufactured by American Dental Research. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K800392 · American Dental Research · Dental device
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Apr 1980
Decision
50d
Days
Class 2
Risk

K800392 is an FDA 510(k) clearance for the BRACKET BONDING SYSTEM METAL & PLASTIC. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by American Dental Research (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 50 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 American Dental Research devices

FDA 510(k) Submission Details - K800392

510(k) Number K800392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1980
Decision Date April 10, 1980
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 128d · This submission: 50d
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 K800392.
HELIOSIT-ORTHODONTIC
K823409 · Vivadent (Usa), Inc. · Jan 1983
ORTHODAPTIC* BONDING ADHESIVE
K823851 · Johnson & Johnson Professionals, Inc. · Jan 1983
INSTA-BOND
K810517 · Lee Pharmaceuticals · Mar 1981
SCI-PHARM ORTHODONTIC ADHESIVE
K791132 · Scientific Pharmaceuticals, Inc. · Aug 1979
SEAL & BOND DIRECT BONDING ORTHODONTIC
K790962 · Scientific Pharmaceuticals, Inc. · Jul 1979
ORTHODONTIC. PLASTIC BRACKET PRIMER
K780028 · 3M Company · Jan 1978