Cleared Traditional

K921245 - THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II

K921245 is an FDA 510(k) clearance for THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II, 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 50-day FDA review.

K921245 · Ormco Corp. · Dental device
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May 1992
Decision
50d
Days
Class 2
Risk

K921245 is an FDA 510(k) clearance for the THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II. 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 May 5, 1992 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 Ormco Corp. devices

FDA 510(k) Submission Details - K921245

510(k) Number K921245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date May 05, 1992
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 127d · 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 134
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K921245.
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
K921283 · Jeneric/Pentron, Inc. · Dec 1992
ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND
K921044 · Wallace A. Erickson & Co. · Nov 1992
CHALLENGE II - PASTE ADHESIVE
K923399 · Ormco Corp. · Oct 1992
IMPROVED SEQUENCE LIGHT CURE ADHESIVE
K921385 · Ormco Corp. · Apr 1992
ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL
K914317 · Confi-Dental Products Co. · Mar 1992
PORCELAIN PRIMER
K920534 · Confi-Dental Products Co. · Mar 1992